MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ULTRAPER PERCUTANEOUS TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	100/563/070
Medical Device Problem Codes	Inflation Problem (1310); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, other text: d4: lot number, expiration date and h4: manufacture date are unknown, no information has been provided to date.G5: 510k is blank, this catalog number is not sold in the united states.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 device did not work as intended, due to the tracheostomy cuff "not holding up".Patient was involved, no patient injury or adverse effects reported.Patient information is not available.The patient was fasted for potential tracheostomy change by tracheostomy team after reviewing in the morning.During the tracheostomy team rounds the cuff pressure was checked and re-inflated.Then rechecked after an hour and confirmed that it had dropped down to 18cm of h20 from 24cm of h20 within an hour.Tracheostomy tube was changed by tracheostomy team consultant.The tracheostomy tube that had been removed was checked by the tracheostomy team and when submerged in water there was water bubbles inside the cuff.
Additional Manufacturer Narrative
Other, other text: d4: udi updated - (b)(4).H6: evaluation codes updated.Device evaluation: one sample was returned.A visual inspection found the sample in good physical condition.The inflation test was done on the received sample.It was confirmed that after 12 hours the cuff was still fully inflated.Based on results of testing the reported failure was not observed.No trend of similar customer complaints was identified.A dhr review was not completed as no lot number was provided.

• Brand Name: PORTEX ULTRAPER PERCUTANEOUS TRACHEOSTOMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 17749230
• Report Number: 3012307300-2023-08919
• Device Sequence Number: 11783562
• Product Code: JOH
• UDI-Device Identifier: 15019517103403
• UDI-Public: 15019517103403
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100/563/070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown