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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN SURGICAL SA DAFILON BLACK 9/0 (0.3) 15CM DRM5 SUTURES

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B BRAUN SURGICAL SA DAFILON BLACK 9/0 (0.3) 15CM DRM5 SUTURES Back to Search Results
Model Number G1111434
Device Problems Break (1069); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). When additional information is received a follow up report will be submitted.

 
Event Description

It was reported by the healthcare professional "needle break and bend easily during freeflab procedure causes bleeding. No major harm to patient. ".

 
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Brand NameDAFILON BLACK 9/0 (0.3) 15CM DRM5
Type of DeviceSUTURES
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
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
8002581946
MDR Report Key8464009
MDR Text Key140312136
Report Number3003639970-2019-00311
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeMY
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 05/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG1111434
Device Catalogue NumberG1111434
Device LOT Number118031
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/18/2019
Event Location No Information
Date Manufacturer Received04/18/2019
Was Device Evaluated By Manufacturer? Yes
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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