MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT27G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405699
Medical Device Problem Code	Measurement System Incompatibility (2982)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that treatment failure occurred after use with tray spn whit27g3.5 l/b-d/e.The following information was provided by the initial reporter, "i¿ve had complaints about two failed spinals from the same lot number.I pulled the rest of the trays off our shelf with this lot number." 2 occurrences were reported, but the date and time and patient information were not given.
Additional Manufacturer Narrative
Investigation: nine samples were received for evaluation.The vials appear as intended with no obvious defects, the fluid is clear with no sign of contamination, manufacturer¿s coc was provided and accepted as a part of incoming raw material inspection and temperature monitoring data demonstrates the drug was stored under suggested conditions at the mannford facility.All indicators suggest product 405699 lot # 0001274709 contained a drug with acceptable potency.Failure mode could not be confirmed.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.A device history record review of all applicable manufacturing records for lot 0001274709 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 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Refer to capa 67717 for additional information regarding the outcome of the investigation.
Event or Problem Description
It was reported that treatment failure occurred after use with tray spn whit27g3.5 l/b-d/e.The following information was provided by the initial reporter, "i¿ve had complaints about two failed spinals from the same lot number.I pulled the rest of the trays off our shelf with this lot number." 2 occurrences were reported, but the date and time and patient information were not given.

• Brand Name: TRAY SPN WHIT27G3.5 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: 8769673
• Report Number: 1625685-2019-00064
• Device Sequence Number: 2043871
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/16/2019

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: 09/30/2020
• Device Catalogue Number: 405699
• Device Lot Number: 0001274709
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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