MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLACK 9/0 (0.3) 13CM PRM5; NYLON SUTURE

Model Number G1118471

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Analysis and results: there are no previous complaints of the same code-batch.We manufactured and distributed in the market 60 units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have not received any sample from the customer for analysis.Without any sample, we cannot carry out an analysis in order to take a decision.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.Needle attachment strength results before releasing the product were 0.050 kgf in average and 0.043 kgf in minimum and fulfilled ep requirements: 0.021 kgf in average and 0.015 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.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.The client reported that when opening the package, the needle is not attached to the thread.The event occurred prior to use on the patient.

• Brand Name: DAFILON BLACK 9/0 (0.3) 13CM PRM5
• Type of Device: NYLON 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: 10126974
• MDR Text Key: 194286609
• Report Number: 3003639970-2020-00222
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2020

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: G1118471
• Device Catalogue Number: G1118471
• Device Lot Number: 618092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/08/2020
• 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