MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN SPT24G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405637
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001263581, medical device expiration date: 2020-06-30, device manufacture date: 2018-09-27.Medical device lot #: 0001268160, medical device expiration date: 2020-06-30, device manufacture date: 2018-10-22.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 anesthesia treatment failure occurred during use with tray spn spt24g3.5 l/b-d/e.The following information was provided by the initial reporter, "anesthesia performed spinal without difficulty - patient not anesthetized - failed spinal we have had 6 spinals in two days that have failed.Kits not kept, so lot number not confirmed.Pulled bd kits with associated lot numbers from spd.We believe there is an issue with the marcaine.Please investigate." 7 occurrences were reported, but the date/time and patient information are not known.
Additional Manufacturer Narrative
Investigation summary: one sample was received for evaluation, however, all necessary components (anesthesia) were not returned to properly evaluate the reported failure mode through sample analysis.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 review of the device history records showed that all inspection results passed per the dhr process and no anomalies were noticed during production.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.Likewise, the investigation identified a summary for previously investigated complaints (pic: ms-002-pic) 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.
Event or Problem Description
It was reported that anesthesia treatment failure occurred during use with tray spn spt24g3.5 l/b-d/e.The following information was provided by the initial reporter, "anesthesia performed spinal without difficulty - patient not anesthetized - failed spinal we have had 6 spinals in two days that have failed.Kits not kept, so lot number not confirmed.Pulled bd kits with associated lot numbers from spd.We believe there is an issue with the marcaine.Please investigate." 7 occurrences were reported, but the date/time and patient information are not known.

• Brand Name: TRAY SPN SPT24G3.5 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: 8732846
• Report Number: 1625685-2019-00056
• Device Sequence Number: 16787329
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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 Catalogue Number: 405637
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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