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

Model Number	100/870/080
Medical Device Problem Codes	Inflation Problem (1310); Tear, Rip or Hole in Device Packaging (2385); Gas/Air Leak (2946)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The day of the event date is unknown.Only the month (b)(6) and year (2020) are known.(b)(6).
Event or Problem Description
It was reported that the cuff component of the blue line ultra (blu) tracheostomy tube was deflating too easily.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu).A sample was returned with p/n 100/870/080 the sample was visually inspected at a close distance of 12-16 with one small tear noted.When cuff tested under submerging in water, the event was verified, as bubbles with coming out.Relevant documents with reviewed upon quality testing and no manufacture discrepancies were revealed prior to release.The cause in theory if could be related to not following manufacture guidelines in section 4 of the ifu 10016503-002 prior to use.The cause is believed the occurrence of leak was after the product left the manufacturing site and care of product by consumer.
Event or Problem Description
Investigation completed on a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu).

• 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: 10469704
• Report Number: 3012307300-2020-08561
• Device Sequence Number: 3538904
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2020

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 Expiration Date: 01/17/2025
• Device Model Number: 100/870/080
• Device Catalogue Number: 100/870/080
• Device Lot Number: 3913697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/29/2020
• Supplement Report FDA Received Date: 10/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1