MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 6/0 (0.7) 45CM DS12; OTHER SUTURE

Model Number C0932060

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/22/2021

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 dafilon suture.The client reports that in the process of suturing child with trauma, the suture was disconnected from the needle.Doctors immediately exchanged for new sutures and took off and wore sterile gloves again.Delayed processing time, child crying irritable.No further information has been received.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have not received any samples.Without closed and/or defective samples a proper analysis cannot be performed.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: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done, and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.We regret any inconvenience this issue may have caused and thank you for your collaboration.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 BLUE 6/0 (0.7) 45CM DS12
• 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: 11767987
• MDR Text Key: 252911375
• Report Number: 3003639970-2021-00148
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K151165
• 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: 05/04/2021

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 Model Number: C0932060
• Device Catalogue Number: C0932060
• Device Lot Number: 619452
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR