MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/090CZ
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.It was found to be a supplied item fault.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.
Event or Problem Description
It was reported that during the use of the product, the inflation line got detached from the pilot balloon.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review one used decontaminated sample was returned for investigation without its original packaging.Under visual inspection we noticed that inflation line was detached from pilot balloon.Product was assembled in tijuana's manufacturing therefore secondary investigation object was created with purpose to capture component investigation.Similar customer complaints have been recently received therefore internal non-conformity report ncr was created with purpose to evaluate this issue.Tijuana's manufacturing site confirmed that no more physical complaint samples were needed for investigation therefore sample were kept in czech republic.No product was returned for second investigation; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Similar customer complaints have been recently received therefore internal non-conformity report corrective and preventive action (capa) was created with purpose to evaluate this issue.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 14626223
• Report Number: 3012307300-2022-11015
• Device Sequence Number: 17240908
• Product Code: BTO
• UDI-Device Identifier: 15019517076172
• UDI-Public: 15019517076172
• 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): 05/06/2023

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: 101/860/090CZ
• Device Catalogue Number: 101/860/090CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/13/2022
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 05/06/2023
• 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
• Patient Sex: Unknown