MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLACK 9/0 (0.3) 13CM PRM5; SUTURE

Model Number G1118471

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

When investigation is complete, a follow-up report will be submitted.

Event Description

It was reported that there was an issue with the dafilon black suture.During the intervention, the thread detached from the needle 3 times - there was no consequence to the patient.The nurse had to remove the threads and suture again, but this lasted about ten minutes so the operating time was not increased by more than 15 minutes.Patient information is not available.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market 144 units.There are no units in stock in b.Braun surgical's warehouse.We have received (b)(4) closed samples.We have tested the needle attachment strength of all the closed samples received and the results fulfill the requirements of the us pharmacopoeia (usp): 0.054 kgf in average and 0.038 kgf in minimum (usp requirements: 0.021 kgf in average and 0.015 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.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.The case is considered not confirmed by evidence of the samples received.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.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 BLACK 9/0 (0.3) 13CM PRM5
• Type of Device: SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9673162
• MDR Text Key: 178029368
• Report Number: 3003639970-2020-00045
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: G1118471
• Device Catalogue Number: G1118471
• Device Lot Number: 619065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1