Medical device manufacturer, B. Braun Surgical, S.A, has issued a medical device safety alert concerning its Safil and Novosyn, sterile absorbable surgical multifilament suture.
From an internal non-conformity, the manufacturer detected that some units of the mentioned products have the pack damaged; as a consequence the product sterility is compromised.
According to the manufacturer, wound infection (e.g. endomyometritis, localized/generalized peritonitis), abscess formation, adhesions, risk of wound dehiscence, sepsis that could lead to life-threatening injury. Treatment or reoperation might be necessary.
The manufacturer would not recommend any specific monitoring of the patients that have been treated with the involved products since there is a risk of infection innate in any type of surgery. The hospital should act according to their established protocol for such complications.
Affected users are instructed to identify and quarantine if the affected product in their warehouse. Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 13 June 2018