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

Catalog Number 405828

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2019

Event Type  malfunction  

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 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 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.

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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8794404
• MDR Text Key: 151295117
• Report Number: 1625685-2019-00073
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405828
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other