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

Model Number	406704
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: 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 4 bd¿ spinal anesthesia trays had holes in their sterile packaging, compromising their sterility.The following information was provided by the initial reporter: "it was reported that there are holes in the sterile covering." "we are experiencing another problem with the spinal tray.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/1/2021.H.6.Investigation: five photos and one physical sample of lot 0001419161 were provided to our quality team for investigation.Through visual inspection, no interior broken components were identified but damage to the interior of the cover packaging was observed, therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001419161 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.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h.10.
Event or Problem Description
It was reported that 4 bd¿ spinal anesthesia trays had holes in their sterile packaging, compromising their sterility.The following information was provided by the initial reporter: "it was reported that there are holes in the sterile covering."."we are experiencing another problem with the spinal tray".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12807069
• Report Number: 1625685-2021-00090
• Device Sequence Number: 12647506
• Product Code: CAZ
• UDI-Device Identifier: 00382904067045
• UDI-Public: 00382904067045
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/25/2022

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: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 406704
• Device Catalogue Number: 406704
• Device Lot Number: 0001419161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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