MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID WHITE 2/0 (3) 100M; OTHER SUTURE

Model Number F1184059

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

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.K990090.Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with supramid white.It was noted that the suture snapped off inside the case and could not be retrieved.There was no patient harm.Additional information was not provided.

Manufacturer Narrative

Samples received: 1 cassette.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 a cassette with the thread broken inside the cassette.Thread was probably tangled in the reel and when pulled out from cassette the thread broke because the extraction was too hard.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 sample received does not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the sample received.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: SUPRAMID WHITE 2/0 (3) 100M
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9274602
• MDR Text Key: 172321615
• Report Number: 3003639970-2019-00773
• Device Sequence Number: 1
• Product Code: GAR
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F1184059
• Device Catalogue Number: F1184059
• Device Lot Number: 618213
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1