MAUDE Adverse Event Report: B. BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 45CM DS24; OTHER SUTURE

Model Number C0932345

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that the suture broke very easily and quickly.This issue occurred during surgery.The needle holder was replaced, but it did not resolve the malfunction with the suture.Additional information has been requested but not yet provided.

Manufacturer Narrative

Samples received: 1 unopened pouch and 1 opened.Analysis and results: there are no previous complaints of this code-batch.We have received one closed sample and one open and used sample with the thread broken.We have tested the knot pull tensile strength of the closed sample received and the results fulfil the requirements of the european pharmacopoeia (ep): xi= 1.23 kgf (ep requirements: 0.51 kgf in average and 0.15 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.Remarks: when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked.Final conclusion: although the result of the closed sample received fulfils 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.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: DAFILON BLUE 4/0 (1.5) 45CM DS24
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8091210
• MDR Text Key: 128047525
• Report Number: 3003639970-2018-00722
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K990090
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932345
• Device Catalogue Number: C0932345
• Device Lot Number: 617011
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/12/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1