MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 1 (4) 100CM HR40 (M) RCP; OPTILENE NON-CARDIOVASCULAR

Model Number C3090100

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that the needle bent during surgery in cesarean case closure.Additional patient and event details have been requested.

Manufacturer Narrative

Manufacturing evaluation: samples received: 1 unopened racepack.Analysis and results: there are no previous complaints of this code-batch.There are no units in our stock.The needle of the sample received have been tested for bending strength and the result fulfill product specifications care should be taken to avoid damage when handling surgical needles.Grasp the needle in an area one-third (1/3) to one half (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage.Reviewed the batch manufacturing record of this product, there are no incidences related to this issue and it was released into the market fulfilling usp/ep and b.Braun surgical requirements.Final conclusion:although the result of the sample received fulfil b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: OPTILENE 1 (4) 100CM HR40 (M) RCP
• Type of Device: OPTILENE NON-CARDIOVASCULAR
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9835782
• MDR Text Key: 183567951
• Report Number: 3003639970-2020-00155
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K180321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090100
• Device Catalogue Number: C3090100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1