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U.S. Department of Health and Human Services

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

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B.BRAUN MEDICAL INC CONT. EPIDURAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 332220
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2019
Event Type  malfunction  
Event Description
Epidural catheter had become disconnected from the tubing at the yellow connector clamp. This clamp had popped open allowing the catheter to slide out and place the patient at a higher risk for infection. The clamp was taped closed since the device is known to come undone. However, it still was able to pop open. The epidural was required to be removed and the epidural medication had to be discontinued. Pain management had to be adjusted due to the clamp coming undone.
 
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Brand NameCONT. EPIDURAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B.BRAUN MEDICAL INC
MDR Report Key8416485
MDR Text Key138764140
Report NumberMW5084857
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model Number332220
Device Catalogue NumberGTIN 04046964178313
Device Lot Number0061628279
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/12/2019 Patient Sequence Number: 1
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