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

Catalog Number	405672
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8190533
• Report Number: 1625685-2018-00066
• Device Sequence Number: 16804480
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 405672
• Device Lot Number: 0001263336
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other