MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN QNKE22G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405609
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 ineffective anesthesia occurred during use with a tray spn qnke22g3.5 l/b-d/e.The following information was provided by the initial reporter, "health professional reported that the drug bupivacaine in several of the trays was not working.This did occur on patients occurred at least 4 separate instances." 4 occurrences were reported.
Event or Problem Description
It was reported that ineffective anesthesia occurred during use with a tray spn qnke22g3.5 l/b-d/e.The following information was provided by the initial reporter, "health professional reported that the drug bupivacaine in several of the trays was not working.This did occur on patients occurred at least 4 separate instances." 4 occurrences were reported.
Additional Manufacturer Narrative
Two samples were received for evaluation.The liquid was clear with no noticeable imperfections.The ampule was in good condition.The 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.There was a temperature excursion noted but the three remaining temperature probes were within range and the out of range probe was determined to be functioning improperly.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.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 0001292485 did not identify any issues that may have contributed to the reported failure mode.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.The investigation identified a previous capa (capa (b)(4) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Likewise, the investigation identified a summary for previously investigated complaints which provides rationale and information regarding the potential ineffective anesthesia outcome during the use of an anesthesia product code.Based on a review of all of these sources, the current complaint investigation could not identify a definitive root cause nor could any potential contributor be identified for this specific complaint failure mode.

• Brand Name: TRAY SPN QNKE22G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9245634
• Report Number: 1625685-2019-00121
• Device Sequence Number: 2019331
• Product Code: CAZ
• UDI-Device Identifier: 00382904056094
• UDI-Public: 00382904056094
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• 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): 12/12/2019

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: 03/31/2021
• Device Catalogue Number: 405609
• Device Lot Number: 0001292485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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