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

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.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR SPINAL ANESTHESIA
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10349481
• MDR Text Key: 201198165
• Report Number: 10349481
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400866
• Device Lot Number: 0001345574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Weight: 90