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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR SPINAL ANESTHESIA ANESTHESIA CONDUCTION KIT

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BECTON, DICKINSON AND COMPANY 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR SPINAL ANESTHESIA ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 400866
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Pain (1994)
Event Date 07/17/2020
Event Type  malfunction  
Event Description
Incident description: failed spinal that converted to general anesthesia. Easy spinal, first attempt with free flow of csf, positive swirl in syringe at beginning, middle and end of injection of 1/8 ml of 0. 75 % marcaine (from pyxis), 200 mcg of duramorph and 10 mcg fentanyl (aoc0091, exp 2020-12). The patient tolerated the c-section until fascia. Foley insertion tolerated, could not feel cold from prep, motor block slow to set up, patient level t6-7, placed in trendelenburg. Patient passed surgeon testing but did not tolerate once they reached the fascial layer. From the operative report: description of procedure: patient was taken to the operating room where regional anesthesia was maintained and then prepped and draped in the normal sterile fashion in the left lateral tilt position. Time out was taken and verified x3. At 0949 a pfannenstiel incision was made with a scalpel, and carried down to the fascia with electrocautery. Due to excessive pain, anesthesia converted to general with the glide scope at 1003. The c-section was carried out with no complications.
 
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Brand Name25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR SPINAL ANESTHESIA
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key10349481
MDR Text Key201198165
Report Number10349481
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 07/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number400866
Device Lot Number0001345574
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/29/2020
Event Location Hospital
Date Report to Manufacturer07/31/2020
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

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