MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 3/0 (2) 75CM HS21 (M) RCP; OTHER SUTURE

Model Number C3090461

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

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

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.Investigation: samples received: 45 unopened racepacks.Analysis and results: there are no previous complaints of the same reference-batch.We manufactured 540 units of this code-batch.There are 36 units in our stock that have been blocked.Sewing test on artificial skin tissue has been conducted with some closed samples received and fraying/damaged surface appears in some units when pulling the thread through the tissue (see picture enclosed after conducting sewing test).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 b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in some 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.No corrective/preventive actions needed.

Event Description

It was reported that the thread is fraying during surgery.The reporter indicated that during carpal tunnel procedures on subcutaneous and/or skin closure the suture thread frays.Per the reporter, this is not the first time that the fraying occurs.Patient data is not available.

• Brand Name: OPTILENE 3/0 (2) 75CM HS21 (M) RCP
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa, 121; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 9452577
• MDR Text Key: 172607889
• Report Number: 3003639970-2019-00875
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

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: C3090461
• Device Catalogue Number: C3090461
• Device Lot Number: 119246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1