MAUDE Adverse Event Report: CAREFUSION, INC TRAY SFTY SPN WHIT25G3.5 L/B-D/E 1T7457; 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	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that tray sfty spn whit25g3.5 l/b-d/e 1t7457 sterile covering was damaged.The following information was provided by the initial reporter: it was reported by the distributor that there is a hole in the sterile covering.
Event or Problem Description
It was reported that tray sfty spn whit25g3.5 l/b-d/e 1t7457 sterile covering was damaged.The following information was provided by the initial reporter: it was reported by the distributor that there is a hole in the sterile covering.
Additional Manufacturer Narrative
H6: investigation summary: one photo of lot 0001400915 was provided.No photos or samples of showing the reported issue were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for reported lot 0001400915 was performed and it was confirmed that procedural and functional requirements needed for its release were met.It can be concluded that during the review of the information available, any non-conformance or quality issues were not observed or identified.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: TRAY SFTY SPN WHIT25G3.5 L/B-D/E 1T7457
• 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: 12297682
• Report Number: 1625685-2021-00050
• Device Sequence Number: 14235634
• 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: SEE H.10
• 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): 01/14/2022

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: 01/31/2022
• Device Model Number: 406704
• Device Catalogue Number: 406704
• Device Lot Number: 0001400915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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