MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL MINIPACKS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/391/128CZ

Device Problem Break (1069)

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

Event Date 05/28/2020

Event Type  malfunction  

Event Description

It was reported that when attempting to connect filter to the device the locking mechanism fell off and was in no way attached.No patient injury was reported.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX EPIDURAL MINIPACKS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; building 23, level 2,; minneapolis, MN 55442
• MDR Report Key: 15310824
• MDR Text Key: 305361912
• Report Number: 3012307300-2022-16496
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 100/391/128CZ
• Device Lot Number: 3883014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1