MAUDE Adverse Event Report: CAREFUSION, INC 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	06/28/2019
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.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 separation occurred during use with a tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter, "ob reports stingray connectors are disconnecting from epidural catheters".
Additional Manufacturer Narrative
The changes are as follows: date of event: (b)(6) 2019 date received by manufacturer: 2019-07-29.Medical device lot #: 0001299758 medical device expiration date: 2020-09-30.Device manufacture date: 2019-05-02.
Event or Problem Description
It was reported that separation occurred during use with a tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter, "ob reports stingray connectors are disconnecting from epidural catheters".
Additional Manufacturer Narrative
Investigation summary: sample evaluation was not able to verify the failure mode.When attempting to place the catheter in the stingray connector the catheter was unable to be inserted fully.This does not verify the failure mode since the stingray connectors are one time use and would not work properly when reopened and closed.The most probable root cause of the reported failure mode is improper use of the device.The stingray connector is a one-time use device.If the device was reused it would not function properly.The stingray connector is currently in the process of being replaced.A dhr review of all applicable manufacturing records for lot 0001299758 did not identify any issues that may have contributed to the reported failure mode.
Event or Problem Description
It was reported that separation occurred during use with a tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter, "ob reports stingray connectors are disconnecting from epidural catheters".
Additional Manufacturer Narrative
The changes are as follows: date received by manufacturer: 2019-07-29.
Event or Problem Description
It was reported that separation occurred during use with a tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter, "ob reports stingray connectors are disconnecting from epidural catheters".

• Brand Name: 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: 8854897
• Report Number: 1625685-2019-00082
• Device Sequence Number: 11419275
• 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,Followup,Followup
• Report Date (Section B): 09/18/2019

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 406151
• Device Lot Number: 0001299758
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 07/29/2019; 07/29/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/08/2019; 08/20/2019; 09/18/2019
• 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