MAUDE Adverse Event Report: CAREFUSION, INC BD¿ WHITACRE SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 405672

Device Problem Defective Device (2588)

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

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

Pma / 510(k)#: enforcement discretion.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the "bupivacaine" in the bd¿ whitacre spinal anesthesia tray "was ineffective", and there were ¿some delays in the procedure¿ as a result.There was no report of medical intervention or patient harm.

Manufacturer Narrative

Investigation summary: zero photos or samples were received in the columbus plant for evaluation therefore failure mode could not be verified and root cause could not be determined.A device history record review of all applicable manufacturing records for lot: 0001263336 did not identify any issues that may have contributed to the reported failure mode.Investigation conclusion: 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.Rationale: as a preventive action, the vendor of the applicable drug component (hospira / pfizer) will be notified of the reported failure mode from the customer.Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process if an adverse trend is identified.

Event Description

It was reported that the "bupivacaine" in the bd¿ whitacre spinal anesthesia tray "was ineffective", and there were ¿some delays in the procedure¿ as a result.There was no report of medical intervention or patient harm.

• Brand Name: BD¿ WHITACRE SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8190533
• MDR Text Key: 131201161
• Report Number: 1625685-2018-00066
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10.
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 405672
• Device Lot Number: 0001263336
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other