MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 4/0 (1.5) 45CM DS19; OTHER SUTURE

Model Number C0932205

Device Problems Dull, Blunt (2407); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.4 cases received the same day involving the same 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 not received any samples.As no samples have been received and no units are available in b.Braun surgical, s.A.We have only reviewed the batch manufacturing record and the results during the process fulfill usp/ep and b.Braun surgical requirements.The average penetration results of the needles before releasing the product were 0.412n, 0,396n, 0,377n and 0,406n (average penetration specification: <0.480 n).Needle attachment results conducted on the samples before releasing the product were 0.70 kgf in average and 0.47 kgf in minimum and fulfil ep requirements: 0.46 kgf in average and 0.23 kgf in minimum.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 analyse 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.

Event Description

It was reported that there was an issue with dafilon suture.This defect complaint was initiated by end user (anonymous) on 2020-07-06 to (b)(6) adr center.And adr center refer the case to us on 2020-08-07 with the limited information: the suture is too blunt to be used when stitching.The needle and thread were separated and the thread is not easy to stitch.It is not convenient for doctors to use.The information of user is undisclosed, so there's no possibility to get further information of the case.

• Brand Name: DAFILON BLUE 4/0 (1.5) 45CM DS19
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• Manufacturer Contact: sílvia orús ; carretera de terrassa, 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10481150
• MDR Text Key: 214172556
• Report Number: 3003639970-2020-00319
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K151165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932205
• Device Catalogue Number: C0932205
• Device Lot Number: 619254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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