MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION COMPONENT; ANESTHESIA CONDUCTION KIT

Catalog Number EC-05000

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that there were 2 catheters which are defective: on was bent and the second one shredded.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter shredded.The customer returned one 17ga epidural needle, one epidural catheter w/ stylet, and packaging.The sample was received with the catheter inserted into the needle (reference attached files (b)(4)).It should be noted, an epidural needle is not packaged with epidural component ec-05000.The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed the catheter is damaged as the extrusion is shredded at approximately 30mm from the proximal end.However, the extrusion and coil wire appear not to be stretched (reference files (b)(4)).No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (10171599).The returned catheter measures approximately 90.6cm.This is within the specification of 90.0-90.8cm per graphic c-05000-005gx5; rev 00.None of the catheter appears to be missing.The outer diameter (od) of the returned catheter measured 1.05mm (caliper c05155) which is within the specification of 0.953-1.115mm per graphic c-05000-005gx5; rev 00.A corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of the catheter being shredded was confirmed based upon the sample received.The catheter showed the extrusion was damaged approximately 30mm from the distal end.The ifu warns the user, never tug or quickly pull on catheter during removal from patient to minimize the risk of catheter breakage.A device history record review was performed on the epidural catheter with no relevant findings.Therefore, based upon the condition of the sample received and the observed evidence of the damage to the extrusion, unintentional user error caused or contributed to this event.

Event Description

It was reported that there were 2 catheters which are defective: on was bent and the second one shredded.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9693902
• MDR Text Key: 178597490
• Report Number: 1036844-2020-00061
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K801912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: EC-05000
• Device Lot Number: 13F18C0518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 111