MAUDE Adverse Event Report: PRTEX; ANESTHESIA CONDUCTION KIT

Catalog Number NCE6563JP

Device Problems Fluid/Blood Leak (1250); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation results: one epidural catheter was returned with the epifuse connector.When observing the actual catheter, no abnormality such as elongation was observed in the entire catheter, but it was cut diagonally near the marker 8 cm from the tip.There were traces of contact with sharp objects on the cross section of the catheter.The reported event was confirmed.It is highly possible that the catheter broke in contact with the epidural needle tip during use.

Event Description

It was reported that after the customer conducted an artificial joint replacement arthroplasty, medical fluid was leaking from the catheter inserting portion.As leakage persisted the next day, the customer removed the catheter from the patient one day after that.When doing it, no particular resistance was felt through it, but a sound of the catheter being torn off was heard.After the removal, the customer noticed that the fore end part of the catheter was torn off.The customer managed to collect the catheter that remained in the patient (8 cm in length).No further complications were reported in relation to this event.

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PRTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11158007
• MDR Text Key: 226542095
• Report Number: 3012307300-2021-00307
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NCE6563JP
• Device Lot Number: 201026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1