MAUDE Adverse Event Report: NULL PORTEX PEDIATRIC EPIDURAL TRAYS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number NCE6104JP

Device Problem Connection Problem (2900)

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

Event Date 05/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed the catheter slipped off from the connector.So the customer stopped using the product.No patient injury was reported.

Manufacturer Narrative

As a result of the observation of the products, no abnormalities leading to this event were observed.After connecting the catheter to the epifuse connector, a catheter removal test was conducted according to the product standards of overseas manufacturers, and it was confirmed that the product complies with the standards.The root cause was not identified.No lot number was provided; therefore, device history record review could not be completed.Udi, g2, and g5 are nknown.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # 617147.

• Brand Name: PORTEX PEDIATRIC EPIDURAL TRAYS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 15397998
• MDR Text Key: 301740426
• Report Number: 3012307300-2022-18597
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCE6104JP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 09/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: Asian