MAUDE Adverse Event Report: B. BRAUN SURGICAL SA DAFILON BLACK 10/0 (0.2) 15CM DLM6; OTHER SUTURE

Model Number G1118722

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: 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.K990090.When additional information becomes available a follow up will be submitted.

Event Description

It was reported that the thread cut.The reporter indicated that during a surgical procedure, the thread broke during sewing.There was no consequence to the patient.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.There are no units in our stock.We have received 8 closed samples to analyze the complaint.We have tested the knot pull tensile strength of all closed samples received and the results fulfil the requirement of the european pharmacopoeia (ep): 0.028 kgf in average and 0.024 kgf in minimum (ep requirement: 0.010 kgf in average) we have conducted a review of the batch manufacturing record and there was an internal non conformity related to the sterilization cycle.After the resterilization of the product the results before releasing the product fulfilled b.Braun surgical requirements.Remarks: when working with dafilon 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.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 10/0 (0.2) 15CM DLM6
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9536298
• MDR Text Key: 173300353
• Report Number: 3003639970-2019-00942
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: G1118722
• Device Catalogue Number: G1118722
• Device Lot Number: 618301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1