MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/090CZ
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, the pilot balloon got detached from the inflation line.No patient injury.No additional information is available.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: 13 not used (not opened) unit packs 101/860/090cz bluselect 9.0, suctionaid, cuffed, non-fen were received in plastic bag for investigation.10001429-006 infl.Line s/assy soft-seal 9mm is assembled in smiths medical tijuana 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-000928 was created with purpose to evaluate this issue.Smiths medical tijuana site confirmed that no more physical complaint samples are needed for investigation therefore sample is kept in smiths medical czech republic.The cause of the reported problem could not be determined.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.Similar customer complaints have been recently received therefore internal non-conformity report ncr-000928 was created with purpose to evaluate this issue.

• Brand Name: PORTEX TUBES BLUSELECT
• 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 14043774
• Report Number: 3012307300-2022-05970
• Device Sequence Number: 12210407
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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: 101/860/090CZ
• Device Catalogue Number: 101/860/090CZ
• Device Lot Number: 4138175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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