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

Lot Number 3464874

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Six unused samples were received.Visual inspection was performed and found suction lines were bent near the flanges.Functional testing was performed on the returned devices with a flow rate teste finding 4 devices that were conforming and 2 devices were found to be with lower flow rate than specified.The reported problem was confirmed on two of the devices.The root cause of the reported issue was to the manufacturing process.Actions taken to mitigate the issue were a new thermoforming packaging process where the tracheostomy tubes are inserted into the unit pack which doesn't have any retention lugs.Therefore this issue would not occur anymore because after insertion of tracheostomy tube into the unit pack the suction line is unscrewed because it is not hold by any retention lugs.(udi / catalog) is unknown.No product information has been provided to date.

Event Description

It was reported that during testing and before use, the physician noticed the suction line was bent just near the flange.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: 15699925
• MDR Text Key: 306883987
• Report Number: 3012307300-2022-26524
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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: 3464874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer 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