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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 Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going.

 
Event Description

Country of complaint: (b)(6). In the complete plastic service reports that they notice dafilon 9/0 suture too rigid. Also, the knot does not hold and they used to do 1 double knot and 1 flat knot and now they have to do 1 double knot and 2 flat knots to make ensure.

 
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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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key7627398
MDR Text Key112472886
Report Number3003639970-2018-00385
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK990090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2018
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 Number118045
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/19/2018
Event Location No Information
Date Manufacturer Received05/22/2018
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

Patient TREATMENT DATA
Date Received: 06/21/2018 Patient Sequence Number: 1
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