MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 3/0 (2) 45CM HS21; OTHER SUTURE

Model Number G0712264

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

K990090.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.If additional information becomes available a follow-up report will be submitted.

Event Description

It was reported that there was an issue with the supramid black suture.A customer complained that the suture had torn 3 times during the operation.All three had the same lot number.There is no patient information available, but has been requested.

Manufacturer Narrative

Additional infomation: d4, d10 investigation samples received: (b)(4) unopened pouches.Analysis and results: there are no previous complaints of the same code-batch.We manufactured and mostly distributed in the market(b)(4) units of this code-batch.There are 8 units in our stock.We have received 9 closed samples for analysis.We have tested the knot pull tensile strength of all the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.33 kgf in average and 1.24 kgf in minimum (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum) reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: when working with supramid suture materials great care should be taken to ensure that, the use of surgical instruments, such as tweezers and needle holders do not damage the material by being pinched or kinked.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Anyway, you will receive a credit note for one box of product as a quality courtesy for the units sent for analysis.No corrective/preventive needed.

• Brand Name: SUPRAMID BLACK 3/0 (2) 45CM HS21
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9682048
• MDR Text Key: 178218185
• Report Number: 3003639970-2020-00061
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: G0712264
• Device Catalogue Number: G0712264
• Device Lot Number: 619081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1