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

Catalog Number	405673
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 the bd spinal anesthesia tray contained less medication than expected three times.The following information was provided by the client: "bd spinal anesthesia tray- should contain 15mg but he suspects it is closer to 5-6mg.We have a physician questioning the quantity of bupivacaine in the vials included in the kit.He stated each vial should contain 15mg but he suspects it is closer to 5-6mg.He referenced 3 straight cases where this lot number was problematic.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-mar-2022.H6: investigation summary: one photo and three ampules samples were provided to our quality team for investigation.Through visual inspection, the ampule liquids were clear and colorless observed therefore, the reported failure mode was not confirmed.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.
Event or Problem Description
It was reported that the bd spinal anesthesia tray contained less medication than expected three times.The following information was provided by the client: "bd spinal anesthesia tray- should contain 15mg but he suspects it is closer to 5-6mg.We have a physician questioning the quantity of bupivacaine in the vials included in the kit.He stated each vial should contain 15mg but he suspects it is closer to 5-6mg.He referenced 3 straight cases where this lot number was problematic.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13741990
• Report Number: 1625685-2022-00037
• Device Sequence Number: 11971773
• Product Code: CAZ
• UDI-Device Identifier: 00382904056735
• UDI-Public: 0100382904056735
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: 405673
• Device Lot Number: UNKNOWN
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/22/2022
• 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