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

Catalog Number 405699

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).Investigation summary: three photos were provided for evaluation.Vial appears as intended with no obvious defects.Fluid appears to be clear.No avenue to evaluate drug potency without the physical sample.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.As a preventive action, the vendor of the applicable drug component (b)(4) 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 0001270921 did not identify any issues that may have contributed to the reported failure mode.Investigation conclusion: a complaint history check was performed and this is the 4th related complaint reported with the defect/condition of anesthesia ineffective with lot #1270921 regarding item #405699 related complaints: (b)(4).A device history record review of all applicable manufacturing records for lot 0001270921 did not identify any issues that may have contributed to the reported failure mode.Root cause description: 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.Refer to capa (b)(4) for additional information regarding the outcome of the investigation.Likewise, the investigation identified a summary for previously investigated complaints (pic: (b)(4)) 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.Rationale: since no probable root cause was identified for this failure mode, the investigation was not able to identify any corrective actions for this complaint.Based on the reported failure mode, supplier quality notifications were sent to the vendor (b)(4) to notify the vendor of the reported failure mode (anesthesia ineffective).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 Description

It was reported that the anesthesia was ineffective and wore off quickly with a bd tray spn whit27g3.5 l/b-d/e.This occurred on 3 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported that the anesthesia was ineffective and wore off quickly.

• Brand Name: BD TRAY SPN WHIT27G3.5 L/B-D/E
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8865802
• MDR Text Key: 200395516
• Report Number: 1625685-2019-00085
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 405699
• Device Lot Number: 0001270921
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other