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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 6/0 (0.7) 45CM DSMP11 (M) NYLON SUTURE

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B. BRAUN SURGICAL, S.A. DAFILON BLUE 6/0 (0.7) 45CM DSMP11 (M) NYLON SUTURE Back to Search Results
Model Number C0936022
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed 3,204 units in the market. There are no units in stock in b. Braun surgical's warehouse. As no samples have been received and no units are available in b. Braun surgical, (b)(4) we have only been able to review the batch manufacturing record of this product 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. 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 the threads are constantly tearing. Additional information is not provided.

 
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Brand NameDAFILON BLUE 6/0 (0.7) 45CM DSMP11 (M)
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 Key10147327
MDR Text Key194927527
Report Number3003639970-2020-00221
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK990090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC0936022
Device Catalogue NumberC0936022
Device LOT Number619471
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 Received06/18/2020
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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