MAUDE Adverse Event Report: CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA KIT

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Awareness during Anaesthesia (1707); Pain (1994)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. Date of event: unknown. The date received by manufacturer has been used for this field. The initial reporter also notified the fda on 3 august, 2020. Medwatch report # (b)(4). Report source other: medwatch report. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(6).

Event Description

It was reported that 25gx3. 5in whit 5ml glaspak bupi clear anesthesia was ineffective. This was discovered during use. The following information was provided by the initial reporter: material no: 400866 batch no: 0001345574. It was reported that the failed spinal was converted to general anesthesia. Verbatim: failed spine 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 1/8ml of 0. 75% marcaine (from pyxis), 200 mcg of duramorph and 10mcg 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. Patient was taken to the operating room where regional anesthesia was maintained and then prepped and drapped in the normal sterile fashion in the left lateral tilt position. Time out was taken and verified x3. At 0949 a pfannensteil incision was made with a scapel, 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
• Type of Device: ANESTHESIA KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10564353
• MDR Text Key: 208491329
• Report Number: 1625685-2020-00085
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 400866
• Device Lot Number: 0001345574
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/21/2020 Patient Sequence Number: 1