MAUDE Adverse Event Report: TRAY EPID CONT WE18G3.5 C20 LOR5 B DRAP; ANESTHESIA CONDUCTION KIT

Model Number 406048

Device Problem Complete Blockage (1094)

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

Event Date 12/28/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that tray epid cont we18g3.5 c20 lor5 b drap would not allow fluid to flow through it.This was discovered during use.The following information was provided by the initial reporter: material no.: 406048 batch no.: 0001262389.It was reported that fluid would not flow through the epidural catheter.Per phone call on 02-jan-2019: health professional reported that fluid would not come out of the catheter as if there was no hole at the end of it.They had to short delay the procedure to get a new catheter from a tray and restick the patient.

Manufacturer Narrative

H.6.Investigation: one sample was received for evaluation.The sample evaluation was unable to confirm the reported failure mode.There were no visual deformities noted with the catheter.This component is not manufactured at the mannford facility.The complaint investigation was not able to confirm the reported failure mode and no contributing factors were able to be identified.Consequently, a probable root cause could not be identified for the mannford manufacturing facility based on the investigation results.Since the investigation was not able to identify a probable root cause based on the complaint results, no corrective and/or preventive actions are recommended at this time.A device history record review was completed on lot number 0001262389.No issues were noted.

Event Description

It was reported that tray epid cont we18g3.5 c20 lor5 b drap would not allow fluid to flow through it.This was discovered during use.The following information was provided by the initial reporter: material no.: 406048 batch no.: 0001262389 it was reported that fluid would not flow through the epidural catheter.Per phone call on (b)(6) 2019: health professional reported that fluid would not come out of the catheter as if there was no hole at the end of it.They had to short delay the procedure to get a new catheter from a tray and restick the patient.

• Brand Name: TRAY EPID CONT WE18G3.5 C20 LOR5 B DRAP
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9616450
• MDR Text Key: 191579193
• Report Number: 1625685-2020-00002
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904060480
• UDI-Public: 00382904060480
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 406048
• Device Catalogue Number: 406048
• Device Lot Number: 0001262389
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other