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

Model Number 100/541/080CZ

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Samples were received for evaluation without its original packaging.Comparison with bill of material showed that several components which are part of finish good kit were not returned.Based on the provided information and returned samples, it was unable to be determine what was actually missing in the affected kit.Manufacturing processes of this device the manufacture have implemented 100% visual inspections.No trend of similar customer complaints was identified.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that after opening the package it was verified that there was no kit clamp inside the packing.No patient injury was reported.

• Brand Name: PORTEX
• 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; minneapolis, MN 55442
• MDR Report Key: 15417348
• MDR Text Key: 306245399
• Report Number: 3012307300-2022-19085
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K060945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2022

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 Model Number: 100/541/080CZ
• Device Catalogue Number: 100/541/080CZ
• Device Lot Number: 3920449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 09/14/2022
• 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