MAUDE Adverse Event Report: CAREFUSION, INC BD TRAY EPID CONT WE17G3.5 SWC X3796; ANESTHESIA CONDUCTION KIT

Catalog Number	406151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
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.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the sting ray disconnected from the epidural catheter during use with a bd tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter: it was reported that the blue sting ray disconnected from the epidural catheter.The epidural worked fine during labor.I think the blue sting ray got disconnected after delivery but im not sure how/when.
Additional Manufacturer Narrative
One sample was received for evaluation.The sample evaluation was unable to confirm the reported failure mode.Only the connector was returned.The catheter was not returned.The connectors are one-time use and the failure mode cannot be replicated with a used connector.The complaint investigation was not able to confirm the reported failure mode and no contributing factors were able to be identified as p/n 8363805 and 8363809 are supplied parts.Consequently, a probable root cause could not be identified for the mannford manufacturing facility based on the investigation results.A dhr was not performed as the lot number is "unknown" for this complaint.
Event or Problem Description
It was reported that the sting ray disconnected from the epidural catheter during use with a bd tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter: it was reported that the blue sting ray disconnected from the epidural catheter.The epidural worked fine during labor.I think the blue sting ray got disconnected after delivery but i¿m not sure how/when,.

• Brand Name: BD TRAY EPID CONT WE17G3.5 SWC X3796
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9225815
• Report Number: 1625685-2019-00119
• Device Sequence Number: 2090076
• Product Code: CAZ
• UDI-Device Identifier: 00382904061517
• UDI-Public: 00382904061517
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 12/19/2019

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: 406151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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