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

Model Number 101/860/080CZ

Device Problem Separation Problem (4043)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that about ten (10) days after the customer started to use the product, when the customer attempted to perform a suction through the product, the suction line connector got detached.No patient injury.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.Visual and functional tests were performed.One used decontaminated sample was received for investigation without its original packaging.Under visual inspection we noticed that was disconnected from pvc clear bluselect suctionaid.The root cause was undetermined.The complaint sample was resent to the supplier for further evaluation.Supplier evaluation reported: the returned sample was visually inspected at 12? to 16? and normal conditions of illumination according to site visual inspection procedure.The suction line detached from was observed and a lack of solvent was detected; thus, the failure mode reported is confirmed.Based on the analysis conducted in the sample provided, suction line detached failure mode was confirmed.Therefore, the occurrence of this failure condition could be caused by: not enough tetrahydrofuran (thf) solvent at joint.Actions taken-the personnel will quality check that the suction connector is correctly fitted as check that the connector is securely bonded to the tube by slotting the connector into the lifting slot of the 500g.Awareness notification was made to production personnel to explain the importance to adherence or following the procedure by quality engineer.

• Brand Name: PVC - PORTEX TUBES BLUSELECT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16875549
• MDR Text Key: 314623161
• Report Number: 3012307300-2023-05140
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• 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