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

Catalog Number 100/860/080

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 02/01/2020

Event Type  malfunction  

Event Description

It was reported that the customer noticed no product and accessories were inside the package.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The returned sample was received without sample only the original open packaging.Visual inspection: the sample was visually inspected, at a distance of 12" to 16" and normal conditions of illumination.Results: original open packaging with no product inside.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event as described.The probable root causes are: the missing product was occurred in manufacturing site and lack of detection by production personnel; therefore, re-training to manufacturing personnel in the procedure will be initiated as action taken for this issue.Udi unknown, operator of device is unknown, report source is unknown this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 15485062
• MDR Text Key: 302082544
• Report Number: 3012307300-2022-20251
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K210833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 100/860/080
• Device Lot Number: 3867543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1