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

Catalog Number 406047

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8351467
• MDR Text Key: 139180978
• Report Number: 1625685-2019-00009
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other