MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN UNDYED 5/0 (1) 45CM DGMP13; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C0023706

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/08/2021

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 monosyn suture.The client reported that upon opening the package a foreign material was found on the needle.It was detected prior to use and there is no patient involvement.This issue was found only in one package, no other cases were reported.

Manufacturer Narrative

Analysis and results: there are no previous complaints of the same code-batch, of which were manufactured 1,908 units.There were (b)(4) units blocked in stock in b.Braun surgical's warehouse requested to analyze this case.We have not received samples from customer or a picture showing the defect.We have tested the 36 samples from stock.When pulling out the suture from the pack, we have found that particles of the foam and glue remain on some needles.When checking the defective samples, it was found that the needles were wrong placed in the foam, close to the glue between foam and cardboard, which causes glue and foam particles to remain on the needle after suture removal.The most likely root cause of this issue is an operational error in the winding process of these sutures.Some needles were not placed centered in the foam and become impregnated with adhesive and rests of foam when pulling out the suture from package.Checking the samples where the needle is correctly placed in the foam, this issue has not been found.The complaint history record has also been reviewed and we have not received a similar complaint in the last 5 years.Therefore, we consider that this is an isolated and accidental case.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.The personnel involved will be informed of this incidence to avoid this issue occurs again.Final conclusion: taking into account that the samples received from stock do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in 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: MONOSYN UNDYED 5/0 (1) 45CM DGMP13
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 11853898
• MDR Text Key: 251903773
• Report Number: 3003639970-2021-00191
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K011375
• 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: 07/14/2021

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: 05/01/2024
• Device Model Number: C0023706
• Device Catalogue Number: C0023706
• Device Lot Number: 119183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1