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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG CONTIPLEX NERVE BLOCK TRAY

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B. BRAUN MELSUNGEN AG CONTIPLEX NERVE BLOCK TRAY Back to Search Results
Catalog Number 4898710-01
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Malfunction  
Manufacturer Narrative

This report has been identified as b. Braun melsungen ag internal report # (b)(4). No sample has been returned for investigation. Without the actual sample, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event. After checking the respective documentation of the production (shift protocol, results of self-control and in-process control of the workers, machine documentation, cleaning protocol, etc. ), no deviations were found in the period mentioned. If the sample and / or additional pertinent information becomes available, a follow up report will be submitted. Note: this report is being filed for an item number that is not sold in the united states; however, this item or similar items are sold in the united states by b. Braun medical, inc.

 
Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): catheter tip left in a patient.

 
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Brand NameCONTIPLEX
Type of DeviceNERVE BLOCK TRAY
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, pa 
2408332
MDR Report Key10235668
MDR Text Key197846456
Report Number9610825-2020-00132
Device Sequence Number1
Product Code OGJ
Combination Product (Y/N)N
Reporter Country CodeUK
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
Report Date 07/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number4898710-01
Device LOT Number20B05A8701
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 Received06/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/05/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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