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

Catalog Number	405827
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 the filter in tray was leaking with a bd tray cse¿ whit25g4.7 we17g3.5 swc x3794.The following information was provided by the initial reporter: it was reported the flat filter in the tray was leaking.
Additional Manufacturer Narrative
Investigation summary: no sample was returned for analysis.A lot number was not provided, as a result a dhr review was unable to be performed.Without a sample, photograph or lot information the investigation was unable to confirm the reported failure mode.However, based on a previous complaint with a similar failure mode, the design of the flat filter was identified as a potential contributor to the reported failure mode.Based on the previously observed potential for the flat filter to leak, a project has been initiated to redesign the flat filter on the anesthesia syringe assembly to minimize the potential for the flat filter to leak.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences through the quality data analysis system.
Event or Problem Description
It was reported that the filter in tray was leaking with a bd tray cse¿ whit25g4.7 we17g3.5 swc x3794.The following information was provided by the initial reporter: it was reported the flat filter in the tray was leaking.

• 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: 8600281
• Report Number: 1625685-2019-00030
• Device Sequence Number: 3030569
• Product Code: CAZ
• UDI-Device Identifier: 00382904058272
• UDI-Public: 00382904058272
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (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): 06/17/2019

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: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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