MAUDE Adverse Event Report: CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA CONDUCTION KIT

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 10/14/2019

Event Type  malfunction  

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 Description

It was reported that the 25gx3.5in whit 5ml glaspak bupi clear experienced ineffective anesthesia -treatment failed to work during use.The following information was provided by the initial reporter: material no.: 400866, batch no.: 1280749.Per email: lot # for the kit 0001280749.There appears to be an issue with effectiveness/ duration of the meds in the tray? had another spinal that was put in at and the patient was feeling pain, the lot # for the kit 0001280749.

Manufacturer Narrative

H.6 investigation summary: two photos were received for evaluation.The pictures returned were analyzed and the failure mode could not be confirmed.The liquid in the vials was clear and free of visible impurities.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.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 was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that the 25gx3.5in whit 5ml glaspak bupi clear experienced ineffective anesthesia -treatment failed to work during use.The following information was provided by the initial reporter: material no.: 400866 batch no.: 1280749 per email: lot # for the kit 0001280749 there appears to be an issue with effectiveness/ duration of the meds in the tray? had another spinal that was put in at and the patient was feeling pain, the lot # for the kit 0001280749.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9257297
• MDR Text Key: 195567308
• Report Number: 1625685-2019-00123
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 400866
• Device Lot Number: 0001280749
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other