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

Catalog Number	406047
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other occupation: unit supervisor, labor & delivery/high risk ob.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 had disconnected "between the epidural catheter and the yellow tubing", with the tubing "leaking rop/fent on the floor", while 30 minutes later, leakage was also discovered at the "connection piece", which was noticed to be cracked upon replacement.
Additional Manufacturer Narrative
Investigation: one sample was received for evaluation.Visual evaluation confirmed the reported failure mode (damaged connector).The connector was badly cracked at the parting line.The source for the cracking could not be confirmed by the evaluation but based on the reviewed sample, the most likely contributor was identified as over-torqueing of the connector.However, the investigation was not able identify a probable root cause for the observed failure mode since all influences on the connector while in used are not known and not retrievable by this investigation.Since no probable root cause was identified at the manufacturing site or during distribution, the investigation was not able to identify any corrective or preventive actions.A review of the device history records shows that all inspection results passed per the dhr process and no anomalies were noticed during production.
Event or Problem Description
It was reported that the tray epid cont we18g3.5 c20 lor5 s/l/l-e had disconnected "between the epidural catheter and the yellow tubing", with the tubing "leaking rop/fent on the floor", while 30 minutes later, leakage was also discovered at the "connection piece", which was noticed to be cracked upon replacement.

• 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: 8351467
• Report Number: 1625685-2019-00009
• Device Sequence Number: 11162645
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 406047
• Device Lot Number: 0001267373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 03/19/2019
• 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