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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN SPINAL NEEDLE TRAY; ANESTHESIA CONDUCTION KIT
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B. BRAUN MEDICAL INC. PENCAN SPINAL NEEDLE TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 0061582653
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Muscle Weakness (1967); Ambulation Difficulties (2544)
Event Date 03/19/2018
Event Type  malfunction  
Event Description
Four patients were given spinal anesthetic with the pencan spinal needle tray, lot number 0061582653, exp date (b)(6) 2019.One case had to be converted to general anesthetic due to lack of numbness.The other three patients could move their toes and legs, and the surgery continued with the spinal anesthetic.All packages in this lot number were pulled from our storage.The manufacture has been contacted and new product is being shipped.Per hospital, they are sending new product to replace the affected lot.The manufacturer has been very helpful with fixing the issue.
 
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Brand Name
PENCAN SPINAL NEEDLE TRAY
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key7377072
MDR Text Key103677164
Report Number7377072
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 Other
Type of Report Initial
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/30/2019
Device Lot Number0061582653
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2018
Event Location Hospital
Date Report to Manufacturer03/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
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