MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 3/0 (2) 75CM DS24 (M) RCP; OTHER SUTURE

Model Number C3090235

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

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

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K133890.If additional information is available a follow up report will be submitted.

Event Description

It was reported that the thread is fraying.The reporter indicated that the thread is frayed and blue balls are made.Patient data is not available.

Manufacturer Narrative

Samples received: 39 unopened and 1 open race-packs.Analysis and results: there are no previous complaints of this code batch.There are no units in stock in b.Braun surgical's warehouse.We have received 39 closed and 1 open and used sample.The open sample received has the thread surface damaged.Sewing test on artificial skin tissue has been conducted with some of the closed samples received and fraying appears when pulling the thread through the tissue.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: taking into account that the results of samples received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.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 3/0 (2) 75CM DS24 (M) RCP
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9452576
• MDR Text Key: 172609354
• Report Number: 3003639970-2019-00869
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090235
• Device Catalogue Number: C3090235
• Device Lot Number: 118484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1