MAUDE Adverse Event Report: CAREFUSION, INC TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795; ANESTHESIA CONDUCTION KIT

Model Number	405828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
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 cse whit27g4.7 we17g3.5 swc x3795 catheter broke.The following information was provided by the initial reporter: it was reported by the user facility that there are reports of the catheter breaking.
Additional Manufacturer Narrative
H.6.Investigation: three photos were provided to our quality team for investigation.Upon visual inspection of the photo sample, was able to confirm the reported failure mode (broken catheter).A review of the internal manufacturing device record and raw material history files for the lot 0001393406 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.Upon reviewing the production process of the trays 405828, it was identified that the catheters are visually inspected 100% in different parts of the process and in the last 12 months this situation has not been reported in the production line.Complaint investigation has determined the failure to be use related.H3 other text : see h.10.
Event or Problem Description
It was reported that tray cse whit27g4.7 we17g3.5 swc x3795 catheter broke.The following information was provided by the initial reporter: it was reported by the user facility that there are reports of the catheter breaking.

• Brand Name: TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795
• 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: 11941348
• Report Number: 1625685-2021-00041
• Device Sequence Number: 4066297
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/06/2021

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: 12/31/2021
• Device Model Number: 405828
• Device Catalogue Number: 405828
• Device Lot Number: 0001393406
• 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: 05/07/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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