MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/189/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on october 28, 2023, the patient suffered from gastrointestinal bleeding and underwent emergency tracheal intubation to protect the airway.Before intubation, the doctor checked the no.7.5 suction tracheal intubation tube and immersed the balloon in sterile saline which had bubbles.This was taken as an indication of leaking.The airbag was discarded and replaced with another tracheal intubation tube.There was no patient adverse effects.
Additional Manufacturer Narrative
Other text: device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
D4: udi updated.Udi related data quality updates only.

• Brand Name: PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18232001
• Report Number: 3012307300-2023-10827
• Device Sequence Number: 3176696
• Product Code: BTR
• UDI-Device Identifier: 15019315059537
• UDI-Public: (01)15019315059537(11)220809(17)270722(10)4264597
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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 Catalogue Number: 100/189/075
• Device Lot Number: 4264597
• Was Device Available for Evaluation?: No
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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 Age: 85 YR
• Patient Sex: Male