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	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.H a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that breakage occurred at an unspecified time with a tray cse whit27g4.7 we17g3.5 swc x3795.The following information was provided by the initial reporter, "epidural catheter broke.".
Additional Manufacturer Narrative
Investigation: the sample evaluation was able to confirm the reported failure mode.The catheter was observed to be ripped and the coil was shown to be partially ripped out of the catheter.The complaint investigation was able to confirm the reported failure mode but no contributing factors were able to be identified as the parts involved in this incident are supplied parts and a lot number was not provided.Consequently, a probable root cause could not be identified for the manufacturing facility based on the investigation results.
Event or Problem Description
It was reported that breakage occurred at an unspecified time with a tray cse whit27g4.7 we17g3.5 swc x3795.The following information was provided by the initial reporter, "epidural catheter broke.".

• 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: 9112489
• Report Number: 1625685-2019-00113
• Device Sequence Number: 2360511
• 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: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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