MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID WHITE 2 (5) 50M; SUTURES

Model Number F1184083

Device Problem Product Quality Problem (1506)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It is reported that the stock of supramid usp 2, appears that the thickness of the suture is actually a size 1.

Manufacturer Narrative

Samples received: 1 open cassette.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed into the market (b)(4) units.There are no units in stock in b.Braun surgical warehouse.We have received an open cassette.We have tested the diameter of the remaining thread inside the cassette received and the results do not fulfill the requirements of the european pharmacopoeia (ep) for a usp 2 size: 0.443 mm in average (ep requirements: diameter average between 0.500 and 0.599 mm).The diameter corresponds to a usp 1 size (average diameter between 0.400 and 0.499 mm).We have also tested the knot pull tensile strength of the thread in the open cassette received and the results fulfill the requirements of the european pharmacopoeia (ep) for this product and usp size 2: 4.83 kgf in average and 4.40 kgf in minimum (ep requirements: 3.57 kgf in average and 2.24 kgf in minimum).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.Diameter values tested during the production are from 0.514 mm in minimum and 0.590 mm in maximum, fulfilling ep requirements for usp 2 size.A capa has been opened to determine root cause, nevertheless, as no other customer complaints have been received we assume a small variation of thread diameter in the raw material that lead to a smaller diameter in some parts of the spool.Final conclusion: taking into account that the results of sample received does 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.Corrective/preventive actions: according to our internal procedures, we have opened a capa in order to determine root cause of the defect and actions: capa/cc/w/02/mar/2018.

• Brand Name: SUPRAMID WHITE 2 (5) 50M
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7051116
• MDR Text Key: 93434427
• Report Number: 3003639970-2017-00561
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F1184083
• Device Catalogue Number: F1184083
• Device Lot Number: 617045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2017
• Date Manufacturer Received: 10/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other