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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT
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BECTON, DICKINSON & CO. SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 400866
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/27/2020
Event Type  malfunction  
Event Description
Incident description: failed spinal - positive cerebrospinal fluid (csf) aspiration, 1. 8ml 0. 75% marcaine, 200 mcg duramorph, 10 mcg fentanyl given after positive csf aspiration. After medications were injected, again positive aspiration was noted as well. Spinal not adequate for surgery - general anesthesia needed. 0. 75% marcaine, manufactured by baxter, lot# a0c0091. Note from the operative report: "the patient was taken to the operating room where spinal anesthesia was administered, but was not adequate to control the pain. She had to be converted to general. " there were no complications noted. Note: the top label of the package was not saved; unknown manufacturer of spinal tray. The side of the spinal tray had the reference numbers but no product name.
 
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Brand NameSPINAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON, DICKINSON & CO.
1 becton drive
franklin lakes NJ 07417
MDR Report Key10539831
MDR Text Key207187913
Report Number10539831
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400866
Device Lot Number0001345574
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2020
Event Location Hospital
Date Report to Manufacturer09/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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