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

Catalog Number	405828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.
Event or Problem Description
It was reported that the tray cse whit27g4.7 we17g3.5 swc x3795 catheter disconnected from the connector after the placement during use.The following information was provided by the initial reporter: "it was reported that the catheter disconnected from the connector after placement.Placed second catheter with no aes.".

• 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: 8703858
• Report Number: 1625685-2019-00050
• Device Sequence Number: 16715777
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial 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