MAUDE Adverse Event Report: CAREFUSION, INC BD TRAY CSE WHIT25G4.7 WE17G3.5 SWC X3794; ANESTHESIA CONDUCTION KIT

Catalog Number	405827
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that there were broken filter wheels in the trays with a bd tray cse whit25g4.7 we17g3.5 swc x3794.This occurred on 3 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported that there was issues with broken filter wheels in the trays.
Additional Manufacturer Narrative
Investigation: a customer provided photograph was available for analysis.Visual analysis could not confirm the reported failure mode (broken filter wheel).It was noted that the luer lock in the photograph was not included in the tray (foreign componentry used) and that the stingray connector was closed prior to catheter assembly.In order to function correctly the stingray connector should be open until the completion of catheter assembly, these usage instructions are included in the ifu.Lastly, the filter wheel appeared in to be good condition.The investigation was unable to confirm the failure mode nor identify a probable root cause.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.A lot number was not provided, as a result a dhr review was unable to be performed.
Event or Problem Description
It was reported that there were broken filter wheels in the trays with a bd tray cse whit25g4.7 we17g3.5 swc x3794.This occurred on 3 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported that there was issues with broken filter wheels in the trays.

• Brand Name: BD TRAY CSE WHIT25G4.7 WE17G3.5 SWC X3794
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8818007
• Report Number: 1625685-2019-00077
• Device Sequence Number: 2839188
• Product Code: CAZ
• UDI-Device Identifier: 00382904058272
• UDI-Public: 00382904058272
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 405827
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other