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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 4/0 (1.5) 75CM DS19 OTHER SUTURE

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B.BRAUN SURGICAL SA SUPRAMID BLACK 4/0 (1.5) 75CM DS19 OTHER SUTURE Back to Search Results
Model Number C0714208
Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Pma/510k: reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. K990090. Samples received: there are no samples available. Analysis and results: there are no previous complaints of the same code-batch. We manufactured and distributed in the market 2,088 units of this code-batch. There are no units in our stock. We have not received any sample for analysis. Without any samples we cannot carry out an analysis in order to take a decision. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b. Braun surgical requirements. Needle attachment strength results on samples during the process were 0. 96 kgf in average and 0. 64 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep requirements: 0. 46 kgf in average and 0. 23 kgf in minimum). Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications. In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence. Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it. Please note that when no samples are received our analysis is very limited. Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product. No corrective/preventive actions needed.

 
Event Description

It was reported that there is an issue with a needle detachment. The reporter indicated that the thread split from the needle. Additional information is not available. Patient information is not available.

 
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Brand NameSUPRAMID BLACK 4/0 (1.5) 75CM DS19
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
carretera de terrassa, 121
rubi, barcelona 08191
SP   08191
MDR Report Key9837256
MDR Text Key183664405
Report Number3003639970-2020-00130
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeHU
PMA/PMN NumberSEE H10
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
Report Date 03/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC0714208
Device Catalogue NumberC0714208
Device LOT Number618521V030
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2020
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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