MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number ASK-05500-NRON

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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 the catheter migrated from the patient's body while in use.Therefore, a new catheter was inserted in the patient.The customer would like us to check if the catheter extended.According to the customer if the catheter extended the migration might have been caused by the patient.Additional information indicates that the term extended means that the catheter stretched.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter "migrated" from the patient.The customer also stated after the catheter migrated, the catheter looked extended (stretched).The customer returned one flat filter nrfit, one snaplock assembly nrfit, and one epidural.The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed both components appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used as adhesive can be seen on the outer extrusion.The returned catheter also appears to be slightly stretched at the distal end.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (10171599).The returned catheter extrusion measures approximately 90.8cm.The extrusion and coil wire appear to be slightly stretched at the distal end of the catheter.Even with the slight stretching, the catheter is still within the specification of 88.5-91.5 cm per graphic kz-05400-030 rev.04.Specifications per graphic kz-05400-030 rev.04 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.7, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the catheter stretching during use was confirmed based upon the sample received.Visual examination of the returned catheter revealed the distal end of the catheter appeared to be slightly stretched.The ifu for this product warns the user never tug or quickly pull on catheter during removal and do not apply additional tension if the catheter begins to stretch as there is a risk for separation.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.It is unknown how the catheter was handled prior to and during use.Therefore, the potential cause of the catheter stretching could not be determined.

Event Description

It was reported that the catheter migrated from the patient's body while in use.Therefore, a new catheter was inserted in the patient.The customer would like us to check if the catheter extented.According to the customer if the catheter extended the migration might have been caused by the patient.Additional information inidcates that the term extended means that the catheter stretched.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 11030499
• MDR Text Key: 222687242
• Report Number: 3006425876-2020-01106
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F20G1645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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