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

Model Number	100/897/080
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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 or Problem Description
It was reported that the balloon would not inflate.They tried several times, but nothing worked.No medical intervention was required.
Additional Manufacturer Narrative
No sample was returned for investigation, a photo of the reported condition was added for investigation.According to what is observed in the photo, it is not possible to confirm if the product has any leaks or any condition that would cause the cuff to fail to inflate.The complaint was not confirmed.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, icu medical will reopen this complaint for further investigation.A device history (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Additional Manufacturer Narrative
D4: udi updated.Udi related data quality updates only.

• Brand Name: PORTEX TUBES PDT UNIPERC
• Common Device Name: 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 ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 17961399
• Report Number: 3012307300-2023-09751
• Device Sequence Number: 20088757
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: (01)15019315060441(11)211101(17)261014(10)4156981
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: 100/897/080
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 4156981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 02/22/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown