MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E; ANESTHESIA CONDUCTION KIT

Catalog Number	406047
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma / 510(k)#: enforcement discretion.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 the tray epid cont we18g3.5 c20 lor5 s/l/l-e connector between the catheter and epidural syringe pulled apart.
Event or Problem Description
It was reported that the tray epid cont we18g3.5 c20 lor5 s/l/l-e connector between the catheter and epidural syringe pulled apart.
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review of all applicable manufacturing records for lot 0001260638 did not identify any issues that may have contributed to the reported failure mode.

• Brand Name: TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8210135
• Report Number: 1625685-2018-00062
• Device Sequence Number: 2879572
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• 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): 02/20/2019

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 406047
• Device Lot Number: 0001260638
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No