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

Catalog Number 100/515/080

Device Problem Defective Component (2292)

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

Event Date 08/31/2018

Event Type  malfunction  

Event Description

It was reported that the suction line at the upper part of the cuff came off.No patient injury reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed it was received in used conditions without its original packaging.The suction line was detached from the flange.Customer?s reported issue was confirmed.Line clearance record shows no discrepancies were found.Training records of the operators that performs the suction line bonding operation and weight test shows no discrepancies were found.Suction line bonding operation was reviewed shows no discrepancies were found.Weight test was reviewed shows no discrepancies were found.The root cause of the reported issue was determined.The most probable cause is that the operator applied methylene chloride instead of tetrahydrofuran, since the dispensers were similar.Actions taken to mitigate the reported issue: corrective actions were taken.The manufacturing personnel was notified by the quality engineer about failure mode reported by the customer.D4: udi information is unknown.

• 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: 15670939
• MDR Text Key: 306985178
• Report Number: 3012307300-2022-26214
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2022

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 Catalogue Number: 100/515/080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/25/2022
• 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