MAUDE Adverse Event Report: CAREFUSION, INC BD¿ SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	405735
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 an unspecified number of bd¿ spinal anesthesia trays' bupivacaine failed to work during the spinal treatments.The following information was provided by the initial reporter: "issue: anesthesia had multiple failed spinals with a specific lot of spinal kits - within those kits is bupivacaine; the suggestion is this medication is defective and ineffective.".
Event or Problem Description
It was reported that an unspecified number of bd¿ spinal anesthesia trays' bupivacaine failed to work during the spinal treatments.The following information was provided by the initial reporter: "issue: anesthesia had multiple failed spinals with a specific lot of spinal kits - within those kits is bupivacaine; the suggestion is this medication is defective and ineffective.".
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 04-oct-2023 h.6.Investigation summary: one sample was provided to our quality team for investigation.Through visual inspection of the tray sample no issues were observed with the marcaine/bupivacaine per our visual inspection standard; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001515575 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.The sterilization record was reviewed, no issues were identified.Retain samples were analyzed, per the drug retain visual examination procedure, and no issues were identified.Based on the available information we are not able to identify a root cause at this time.A notification has been sent to the supplier, along with a request that they analyze their retains.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: BD¿ SPINAL ANESTHESIA TRAY
• Common Device Name: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17553230
• Report Number: 1625685-2023-00079
• Device Sequence Number: 11991376
• Product Code: CAZ
• UDI-Device Identifier: 00382904057350
• UDI-Public: 00382904057350
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 405735
• Device Lot Number: 0001515575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown