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

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd¿ 25gx3.5in whit 5ml glaspak bupi clear has been found with ineffective anesthesia during use.The following has been provided by the initial reporter: it was reported that the bupivicaine in the spinal tray did not work while anesthesiologist was in procedure.Bupivicaine in spinal tray did not work while anesthesiologist was in procedure.

Manufacturer Narrative

Investigation: a customer provided photographs were provided.The photograph returned does not include the sample.Sample could not be visually evaluated as a result.Failure mode could not be confirmed.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.Specific to the handling of the drugs, the investigation noted specific procedures to control the handling of any raw material drug component during the receipt, storage, and use in the manufacturing process.A review of the temperature monitoring system within the mannford facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications.The causes of ineffective anesthesia have been well documented in clinical literature for many years.Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained.Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system.As a preventive action, the vendor of the applicable drug component (hospira / pfizer) will be notified of the reported failure mode from the customer.A device history record review of all applicable manufacturing records for lot 0001282624 did not identify any issues that may have contributed to the reported failure mode.

Event Description

It has been reported that one bd¿ 25gx3.5in whit 5ml glaspak bupi clear has been found with ineffective anesthesia during use.The following has been provided by the initial reporter: it was reported that the bupivicaine in the spinal tray did not work while anesthesiologist was in procedure.Bupivicaine in spinal tray did not work while anesthesiologist was in procedure.

• Brand Name: BD¿ 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: 9458750
• MDR Text Key: 176767702
• Report Number: 1625685-2019-00140
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 400866
• Device Lot Number: 0001282624
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other