MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Connection Problem (2900)

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

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported that when connecting the needle to the syringe, the customer noticed the connection between them was unstable.No patient injury was reported.

Manufacturer Narrative

A 25g needle and a 10ml syringe were returned.Visual inspection found no abnormalities in appearance.When the samples were connected, it was confirmed that the connection was successful, but the connection was rather shallow and weak.When the inner diameter of the female connector of the injection needle and the outer diameter of the male connector of the syringe were inspected with an inspection gauge, it was confirmed that they conformed to the standard.The reported event was not confirmed.A device history record (dhr) review was not performed as no lot or serial numbers were provided.D4 and g5 are unknown.No information is provided to date.D5 operator of device is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 15315949
• MDR Text Key: 305069135
• Report Number: 3012307300-2022-16597
• 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: 08/29/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1