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

Model Number 101/810/080

Device Problems Break (1069); Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event is unknown; no information has been provided to date.D3, g1,2 email is: regulatory.Responses@icumed.Com.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that a patient had two (2) cannulas delivered, and both were found to be faulty (broken) at opening and unable to be used.No patient injury or clinical affects was reported and the outcome was reported as resolved.(b)(6) and (b)(6) represent the same patient.

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.H6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Under visual inspection it was noticed that the inflation line was detached from pilot balloon as reported by customer.The complaint was confirmed.This was attributed to a supplied item fault.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• 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: reed covert
• MDR Report Key: 18326511
• MDR Text Key: 330498161
• Report Number: 3012307300-2023-11063
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076301
• UDI-Public: 15019517076301
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101/810/080
• Device Catalogue Number: 101/810/080CZ
• Device Lot Number: 4230143
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1