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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. UNKNOWN ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 61515181
Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2017
Event Type  malfunction  
Event Description
Certified registered nurse anesthesiologist (crna) inserted an epidural catheter and when attempting to thread the catheter, met resistance. Attempted to pull epidural catheter out of needle, end of the catheter was broken off. Removed needle and the tip of the catheter that had broken off was stuck in the epidural needle. No harm to patient.
 
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Brand NameUNKNOWN
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown PA 18109
MDR Report Key6848280
MDR Text Key85135801
Report Number6848280
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number61515181
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/16/2017
Event Location Hospital
Date Report to Manufacturer08/16/2017
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

Patient Treatment Data
Date Received: 09/07/2017 Patient Sequence Number: 1
Treatment
NO
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