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
Event or Problem Description
It was reported by customer that they multiple failed spinals with a specific lot of spinal kits - within those kits is bupivacaine; the suggestion is this medication is defective and ineffective.Verbatim: 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
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 0001515575.D4.Medical device expiration date:28feb2025.H4.Device manufacture date: 27apr2023.D4.Medical device lot #: 0001517225.D4.Medical device expiration date: 25jun2025.H4.Device manufacture date: 11may2023.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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: 03-oct-2023.H.6.Investigation summary: nine trays were received by our quality team for investigation.Upon visual inspection, it was observed that they are smiths medical anesthesia trays, not bd anesthesia trays; 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 numbers 0001515575, 0001517225 were 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.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported by customer that they multiple failed spinals with a specific lot of spinal kits - within those kits is bupivacaine; the suggestion is this medication is defective and ineffective.Verbatim: 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.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17603969
• Report Number: 1625685-2023-00080
• Device Sequence Number: 6139586
• Product Code: CAZ
• UDI-Device Identifier: 00382904057350
• UDI-Public: (01)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: Health Professional
• Device Catalogue Number: 405735
• Device Lot Number: SEE H.10
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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