MAUDE Adverse Event Report: CAREFUSION, INC BD¿ TRAY SPN WHIT25G3.5 B-D/L X3802; ANESTHESIA CONDUCTION KIT

Catalog Number	405741
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ tray spn whit25g3.5 b-d/l x3802 was ineffective and did not numb the patient.This occurred on 3 separate occasions.The following information was provided by the initial reporter: ¿material no.: 405741.Batch/lot: 0001283015.It was reported that the "bupivacaine in tray was infective and did not numb the patient.Drug did not work properly.".Customer text: "bupivacaine in tray was ineffective and did not numb the patient.Drug did not work properly.".
Additional Manufacturer Narrative
Investigation summary: no samples were received for evaluation.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 (hospital / 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.A device history record review of all applicable manufacturing records for lot 0001283015 did not identify any issues that may have contributed to the reported failure mode.Root cause is undetermined.
Event or Problem Description
It was reported that bd¿ tray spn whit25g3.5 b-d/l x3802 was ineffective and did not numb the patient.This occurred on 3 separate occasions.The following information was provided by the initial reporter: ¿material no.: 405741.Batch/lot: 0001283015.It was reported that the "bupivacaine in tray was infective and did not numb the patient.Drug did not work properly." customer text: "bupivacaine in tray was inffective and did not numb the patient.Drug did not work properly."".

• Brand Name: BD¿ TRAY SPN WHIT25G3.5 B-D/L X3802
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8464536
• Report Number: 1625685-2019-00019
• Device Sequence Number: 18880208
• Product Code: CAZ
• UDI-Device Identifier: 00382904057411
• UDI-Public: 00382904057411
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/24/2019

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: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 405741
• Device Lot Number: 0001283015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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: Required Intervention