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

Catalog Number	406151
Medical Device Problem Codes	Leak/Splash (1354); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
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 device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the catheter from the tray epid cont we17g3.5 swc x3796 disconnected from the stingray during an epidural on an icu patient, and the nurses stated the catheter was not one they had seen before.Additionally, it was reported that the anesthesiologist had to be called in the middle of the night to walk the staff through the situation.The following information was provided by the initial reporter: the other night, the icu had a patient with an epidural catheter that became disconnected.The nurses reported this was not an epidural catheter they had ever seen before.They called anesthesia in the middle of the night and the anesthesiologist talked them through what to do for a disconnect of this type of catheter.
Additional Manufacturer Narrative
Investigation summary: 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 review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
It was reported that the catheter from the tray epid cont we17g3.5 swc x3796 disconnected from the stingray during an epidural on an icu patient, and the nurses stated the catheter was not one they had seen before.Additionally, it was reported that the anesthesiologist had to be called in the middle of the night to walk the staff through the situation.The following information was provided by the initial reporter: the other night, the icu had a patient with an epidural catheter that became disconnected.The nurses reported this was not an epidural catheter they had ever seen before.They called anesthesia in the middle of the night and the anesthesiologist talked them through what to do for a disconnect of this type of catheter.

• 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: 8728223
• Report Number: 1625685-2019-00054
• Device Sequence Number: 19476114
• 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): 07/12/2019

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: Health Professional
• Device Catalogue Number: 406151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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