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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) 45CM DS19 SUTURES

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B.BRAUN SURGICAL SA SUPRAMID BLACK 3/0 (2) 45CM DS19 SUTURES Back to Search Results
Model Number C0712213
Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4) is submitting this report on behalf of b. Braun surgical s. A. (manufacturer). Exemption number: (b)(4). Manufacturing site evaluation: samples received: 19 unopened pouches and 2 opened. Analysis and results: there are no previous complaints of this code-batch. Manufactured and distributed in the market 6,480 units of this code-batch. There are no units in stock. Received 19 closed samples and 5 open and used samples. Three of the five open samples received have the needle detached from the thread and the other two open samples have the cover damaged in some parts of the thread. Furthermore, sewing test on artificial skin tissue has been conducted with the sample received and fraying does not appear when pulling the thread through the tissue. Visual appearance is the usual one as can be seen on enclosed picture, before and after sewing test. Tested the needle attachment of the closed samples received and the results fulfill the oem requirements. The 1. 18 kgf in average and 0. 33 kgf in minimum (ep requirements: 0. 69 kgf in average and 0. 35 kgf in minimum). On the other hand, thread surface in closed samples received after pulling out the threads from the packs is correct and the usual one. No defects have been found. Conducted knotting test with the closed samples received and the thread cover is not damaged after slipping the thread during the knotting test. Final conclusion: although the results of the closed samples received fulfill the oem specifications, note of this incident was taken in order to assess if new or additional actions are needed. 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

Country of complaint: (b)(6). Customer complaints that there must be a production fault with this sutures and have returned 19 unopened samples and 1 bag with 5 defect samples. All from same lot: 617435. The received information from the dentist was that the thread was not fasten to the needle and the colour was wrong.

 
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Brand NameSUPRAMID BLACK 3/0 (2) 45CM DS19
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 Key7511335
MDR Text Key108373370
Report Number3003639970-2018-00266
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeNO
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 05/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC0712213
Device Catalogue NumberC0712213
Device LOT Number617435
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/04/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date04/30/2018
Event Location No Information
Date Manufacturer Received04/16/2018
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: 05/14/2018 Patient Sequence Number: 1
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