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

Catalog Number	405828
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no.405828.Batch no.Unknown.It was reported that during use of the tray cse whit27g4.7 we17g3.5 swc x3795 the hospital had one tray missing tagaderm, one tray missing flat filter, and one tray with a broken glass syringe.Two kits had leaking filters.The following information was provided by the initial reporter: the hospital one tray was missing a tegaderm, another tray missing a flat filter, another tray with broken glass syringe.
Event or Problem Description
Material no.405828 batch no.Unknown it was reported that during use of the tray cse whit27g4.7 we17g3.5 swc x3795 the hospital had one tray missing tagaderm, one tray missing flat filter, and one tray with a broken glass syringe.Two kits had leaking filters.The following information was provided by the initial reporter: the hospital one tray was missing a tegaderm, another tray missing a flat filter, another tray with broken glass syringe.
Additional Manufacturer Narrative
Investigation: two photographs were provided by the customer.Visual analysis of photograph 1 was able to confirm the reported failure mode (broken syringe).No other failure modes were able to be confirmed through analysis of the provided photographs (missing tagaderm, missing flat filter, leakage).Based on the complaint investigation, the most likely contributor to the missing components was identified as the noted components being inadvertently left out of the affected units by the manufacturing personnel.The investigation was not able to identify any probable root cause for the other failure modes included in the complaint description.Regarding the missing components, all applicable manufacturing personnel will received awareness training regarding this complaint failure mode and the manufacturing process for the correct placement of components within the finished good trays.Since no probable root cause was identified for the remaining failure mode included in the complaint description, no corrective or preventive actions were identified for these remaining failure modes.

• 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
• MDR Report Key: 8794404
• Report Number: 1625685-2019-00073
• Device Sequence Number: 14271056
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• 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: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 405828
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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