MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 4/0 (1.5) 45CM HS15; OTHER SUTURE

Model Number C0712043

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Pma/510k: k990090.When additional information is received, a follow up report will be submitted.

Event Description

It was reported the threads (suture) have torn several times during use.No other information has been provided.Additional information has been requested, however, not yet received.

Manufacturer Narrative

Samples received: none.Analysis and results: there are no previous complaints of the same code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have not received any sample for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.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.Knot pull tensile strength results conducted on samples during the process were 1.12 kgf in average and 1.05 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum) 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: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.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.No corrective/preventive actions needed.

• Brand Name: SUPRAMID BLACK 4/0 (1.5) 45CM HS15
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8681293
• MDR Text Key: 151027346
• Report Number: 3003639970-2019-00464
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: C0712043
• Device Catalogue Number: C0712043
• Device Lot Number: 618256V004
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/03/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/09/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1