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

Lot Number UNKNOWN

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A lot number was not reported and therefore a device history record review could not be completed.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A used sample was returned for evaluation without its original packaging.Visual inspection was performed under normal conditions of illumination finding that the inflation line was detached.Based upon testing of devices returned for previous investigation for the same failure mode, it was probable that the inflation line was stretched until it broke.Since the device 100 percent leak test and 100 percent inflation tested during production, it is unlikely that product tested could be cut or detached.The exact root cause of the reported event could not be determined.However, manufacturing personnel have been notified of the reported failure.(udi / catalog) is unknown.No product information has been provided to date.

Event Description

It was reported that during the use of the product at the intensive care unit, a medical staff noticed the suction tube for the pilot balloon was torn off.No patient injury was reported.

• Brand Name: TRACHEOSTOMY/PVC PORTEX TUBES- BLUSELECT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15700428
• MDR Text Key: 306896445
• Report Number: 3012307300-2022-26534
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• 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