Medical device manufacturer, BD, has issued a medical device safety alert concerning its BD PosiFlush Normal Saline Syringe. The affected devices include the following:
| Product Name | Catalog (Ref) No. | Lot No. | Expiration Date | Product Package Size |
|---|---|---|---|---|
| BD PosiFlush Normal Saline Syringes, 3ml SP | 306544 | 0350017 | 2023-12-31 | 480ea/case |
| BD PosiFlush Normal Saline Syringes, 10ml SP | 306546 | 0230853 | 2023-08-31 | 480ea/case |
| 0337072 | 2023-11-30 | 480ea/case | ||
| 0350800 | 2023-12-31 | 480ea/case |
The manufacturer has confirmed that, during transit, a portion of the BD PosiFlush Normal Saline Syringe lots listed above encountered a temperature excursion below the minimum allowable temperature with potential to freeze the product. The temperature excursion has the potential to impact the sterility of the product. When normal saline is subjected to freezing temperatures, the stopper may move from its original position resulting in exposure of the saline to a non-sterile portion of the inside of the barrel. A breach of sterility presents an increased risk of bloodstream infection.
According to the manufacturer, this was an independent incident that local warehouse operators shipped out temperature excursion products by accident. The manufacturing process was not affected hence the subsequent shipments are safe to use.
Affected users should immediately review their inventory for the specific Catalog (Ref) numbers and lot numbers listed above. Affected users should also quarantine and secure the affected products to prevent use by accident. The manufacturer will arrange product exchange for affected users.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Aug 2021