MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TUBES PDT ULTRAPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/596/090

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

No product sample has been provided.The customer provided a photo for evaluation.The photo showed an original product with green (7mm) size block in the upper left corner.The condition observed on the photo does not meet the requirements of labeling artwork for product.Device history record review for the affected lot found that product includes 9 mm trach tube, which corresponds with blue (9 mm) size block on the artwork.Based on the provided evidences the reported by the customer allegation was confirmed.(udi) and pma/510k are unknown.No information is provided to date.Operator of device is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device size is labeled incorrectly.No patient injury was reported.

• Brand Name: PORTEX TUBES PDT ULTRAPERC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15445134
• MDR Text Key: 306072215
• Report Number: 3012307300-2022-19586
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 100/596/090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1993-2021
• Patient Sequence Number: 1