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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 3/0 (2) 100M SUTURES

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B.BRAUN SURGICAL SA SUPRAMID BLACK 3/0 (2) 100M SUTURES Back to Search Results
Model Number F1194046
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: samples received: 1 open cassette. Analysis and results: there are no previous complaints of this code batch. Manufactured and distributed in the market (b)(4) units of this code batch. There are no units in stock. Thread on sample received is broken inside the cassette and it is not useful. Thread was probably tangled in the reel and when pulled out from cassette the thread broke because the extraction was too hard. Final conclusion: it is concluded that the complaint is justified. Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.

 
Event Description

Country of complaint: (b)(6). It was reported that the thread broke and could not be retrieved from the cassette.

 
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Brand NameSUPRAMID BLACK 3/0 (2) 100M
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 Key6723136
MDR Text Key80414624
Report Number3003639970-2017-00370
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberF1194046
Device Catalogue NumberF1194046
Device LOT Number617066
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2017
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date07/10/2017
Event Location No Information
Date Manufacturer Received06/26/2017
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: 07/18/2017 Patient Sequence Number: 1
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