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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL INC. ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical internal report number (b)(4). No samples were returned for evaluation in connection with this incident. Without the actual device, item number, or lot number, a thorough investigation could not be performed. A review of the discrepancy management system (dsms) database was unable to be performed as the lot number was not provided. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
 
Event Description
As reported via the medsun report: the certified registered nurse anesthesiologist (crna) met resistance when attempting to thread the epidural catheter. The crna attempted to pull the epidural catheter out of the needle and noticed the end of the catheter was broken off. The needle was removed and the tip of the catheter was stuck in the epidural needle. No patient injury.
 
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Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown PA 18109
Manufacturer Contact
jonathan severino
901 marcon blvd
allentown, PA 18109
4847197287
MDR Report Key7946561
MDR Text Key125320570
Report Number2523676-2018-00082
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2018
Is this a Product Problem Report? Yes
Device Operator
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 Received09/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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