MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLACK 9/0 (0.3) 15CM DRM6; OTHER SUTURE

Model Number G1118161

Device Problems Detachment of Device or Device Component (2907); Unexpected Color (4055)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an issue with dafilon suture.The client reported that thread colour does not match the description on the primary and secondary packaging.The threads/sutures are transparent, but should be black.In addition, when the doctor pulled out the suture with the holder, the needle came off the suture.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have received two open samples to analyze this complaint.One of the samples contains an undyed thread instead of black with the needle attached to the thread.The other open sample received only contains a detached needle (there is no thread inside).Diameter result conducted on the dafilon sample received is 0.033 mm in average and fulfils the requirements of the european pharmacopoeia (ep) for this size and thread: 0.030 mm < xave < 0.039 mm.Diameter average value is in the medium range of ep requirements for usp 9/0 size.The thread diameter corresponds to a 9/0 size as it should be, but the color of the sample received does not correspond to the product description.On the other hand, we have tested the needle attachment strength of the open sample received and the result does not fulfil the requirements of the united states pharmacopeia (usp).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: taking into account that the results of samples received do not fulfil the united states pharmacopeia /b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in the samples received.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: we opened a corrective action for root-cause investigation and subsequent implementation of actions related.

• Brand Name: DAFILON BLACK 9/0 (0.3) 15CM DRM6
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 11654427
• MDR Text Key: 245427500
• Report Number: 3003639970-2021-00112
• 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: 04/20/2021

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: 04/17/2023
• Device Model Number: G1118161
• Device Catalogue Number: G1118161
• Device Lot Number: 618162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1