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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 3/0 (2) 75CM DS24 OTHER SUTURE

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B.BRAUN SURGICAL SA DAFILON BLUE 3/0 (2) 75CM DS24 OTHER SUTURE Back to Search Results
Model Number C0935352
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2019
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

 
Event Description

It was reported that there was an issue with the dafilon suture. When the packet was open, the user found broken sutures. This happened twice, and it was prior to use. Additional information was not provided.

 
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Brand NameDAFILON BLUE 3/0 (2) 75CM DS24
Type of DeviceOTHER SUTURE
Manufacturer (Section D)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP 08191
Manufacturer (Section G)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP 08191
Manufacturer Contact
silvia orus
121 carretera de terrassa
rubi, 08191
SP   08191
MDR Report Key8957175
MDR Text Key159806704
Report Number3003639970-2019-00625
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeTH
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,Followup
Report Date 09/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC0935352
Device Catalogue NumberC0935352
Device LOT Number618204
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
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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