MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUSELECT DILATION TRACHESTOMY KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/860/080CZ

Device Problem Disconnection (1171)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the suction line came off.As an emergency measure, the product was fixed with medical tape and continued to be used until the time when it would be replaced with next one.No patient injury.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.D4: device expiration date / h4: device manufacturing date are not available because no lot or serial number was provided.H10: device evaluation: one sample was received in used condition without original package.The returned sample was visually inspected under normal conditions of illumination according to the inspection procedure.Per visual inspection, the suction line connector was found to be partially detached.The complaint was confirmed.Based on the analysis conducted, failure mode was confirmed and the occurrence of this failure condition could be caused by the tube not submerged properly in the solvent dispenser or dispenser with low level of solvent.For corrective action, all mitigations in placed were verified and confirmed to have been executed accordingly, where quality and production personnel are trained to perform the connector-to-tube bond inspection and bond test operations as described in procedure.The root cause was traced to manufacturing.No lot or serial number was provided therefore, a device history record dhr review could not be performed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4), corrected data: corrected data:h1: type of reportable event.

• Brand Name: PORTEX BLUSELECT DILATION TRACHESTOMY KIT
• 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 15059200
• MDR Text Key: 296207297
• Report Number: 3012307300-2022-13687
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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 Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1