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

Model Number	100/189/080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event, d4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that while is use with a patient the customer was checking the cuff pressure using the cuff pressure gauge with extension tubing.When the extension tubing was removed, the red cap became detached.No patient injury reported.It has been reported that no additional information will be available for this event.
Additional Manufacturer Narrative
One device was received in used condition without the original packaging.Visual inspection noted a crack was found in the inflation line connector.The device failed a leak test confirming the complaint.As during the pre-check no leakage or damaged was reported, a suspected root cause was due to improper use of the product.A device history record (dhr) review could not be performed as the lot number was unknown.No corrective actions have been taken.

• Brand Name: PORTEX BLUE LINE ULTRA CUFFED TUBE
• 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: jim vegel
• MDR Report Key: 16817019
• Report Number: 3012307300-2023-04586
• Device Sequence Number: 1929923
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: 15019315059544
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081086
• 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): 07/06/2023

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: 100/189/080
• Device Catalogue Number: 100/189/080
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/06/2023
• 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