MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT

Model Number 405672

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter occupation: demand planner, logistics supply chain operations. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0001346903. Medical device expiration date: 2021-10-31. Device manufacture date: 2020-02-28. Medical device lot #: 0001346885. Medical device expiration date: 2021-10-31. Device manufacture date: 2020-02-28. Pma/510(k)#: enforcement discretion. 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 an unspecified number of tray spn whit25g3. 5 l/b-d/e blue drape experienced ineffective anesthesia -failed to work. Product defect occurred during use. The following information was provided by the initial reporter: material no: 405672 ; batch no: 0001346903 , 0001346885. I have just been informed from one of our facilities that the bupivacaine in our bd anesthesia tray (part number 405672) does not work for numbing a patient. They tried 2 trays and neither worked. The lot numbers are 0001346903 (0 kits in the isc, but we will be receiving some back from the facility) and 001346885 (currently 104 kits on hand in the isc).

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10377102
• MDR Text Key: 204736955
• Report Number: 1625685-2020-00071
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/06/2020 Patient Sequence Number: 1