MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 4/0 (1.5) 45CM DS16; OTHER SUTURE

Model Number C0932132

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/17/2021

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 reported that the needle was detached from the thread while the last knot was performing during gingival closure.The suture technique was simple interrupted stitches.There was no patient injury and no additional information has been provided.

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 our stock.We have received an open sample with the needle detached from the thread and the thread is not wound on the pack.However, without any closed sample we cannot carry out an analysis in order to take a decision.We have checked the thread and we have noticed that there are marks of a needle holder or other surgical instrument near the needle attachment area.The thread has been damaged during handling and it broke most probably due to a wrong handling not according to the instructions for use of the product.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.As stated in the instructions for use of the product, 'when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked.' final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.The case is considered not confirmed by evidence of the sample received.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.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 4/0 (1.5) 45CM DS16
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 12880700
• MDR Text Key: 281323294
• Report Number: 3003639970-2021-00624
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K151165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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: C0932132
• Device Catalogue Number: C0932132
• Device Lot Number: 621132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1