MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA SUCTIONAID; BAG, RESERVOIR

Model Number	101/870/070CZ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: under visual inspection we noticed that inflation line was detached from pilot balloon.Similar customer complaints have been recently received therefore internal non-conformity report (b)(4) was created with purpose to evaluate this issue.Returned device had laser printed lot number on its flange.With this information we were able to track down tracheostomy tube assembly work order and lot number of claimed inflation line.A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.
Event or Problem Description
It was reported that during the use of the product, a tear in the cuff was observed.Also, the inflation line was found torn.No patient injury was reported.
Additional Manufacturer Narrative
Under visual inspection we noticed that inflation line was detached from pilot balloon.Similar customer complaints have been recently received therefore internal non-conformity report ncr-000928 was created with purpose to evaluate this issue.Returned device had laser printed lot number on its flange.With this information we were able to track down tracheostomy tube assembly work order and lot number of claimed inflation line.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• Common Device Name: BAG, RESERVOIR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13172473
• Report Number: 3012307300-2022-00177
• Device Sequence Number: 4561726
• Product Code: BTC
• UDI-Device Identifier: 15019517076202
• UDI-Public: 15019517076202
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 101/870/070CZ
• Device Catalogue Number: 101/870/070CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown