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U.S. Department of Health and Human Services

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

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B. BRAUN SURGICAL, S.A. DAFILON BLACK 9/0 (0.3) 13CM PRM5 NYLON SUTURE Back to Search Results
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.

 
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Brand NameDAFILON BLACK 9/0 (0.3) 13CM PRM5
Type of DeviceNYLON 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 Key10126974
MDR Text Key194286609
Report Number3003639970-2020-00222
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK990090
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received06/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG1118471
Device Catalogue NumberG1118471
Device LOT Number618092
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
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

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