MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number	8.0 MM
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received on a smith medical tracheostomy|pvc, portex tubes blue line ultra (blu) malfunctioned.No anomaly in the product was observed at a pre-use check.However, after indwelling it in the patient for a while, the customer noticed the cuff deflated and slipped off from the patient.No patient injury.
Additional Manufacturer Narrative
Other text: device evaluation- one device sample was returned for evaluation.The device examination showed no obvious issues.The device was given functional testing; this showed a leak at the pilot line from a torn area.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.This device type is 100% inflation tested during production.The investigator selected 5 samples from production and attempted to recreate the condition seen in the returned sample.The investigator pressed the devices against a hard surface and pilot lines were pulled.The tear damage seen in the returned sample was duplicated when pull force was applied.The reported issue was determined most likely caused by damage occurring during use.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10538993
• Report Number: 3012307300-2020-09364
• Device Sequence Number: 2793664
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: 15019315038808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: No Information
• Device Model Number: 8.0 MM
• Device Catalogue Number: 100/870/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1