MAUDE Adverse Event Report: TELEFLEX MEDICAL LASERTUBUS 6MM; TUBE, TRACHEAL (W/WO CONNECTO

Model Number	IPN040899
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "leakage during ventilation at the taped connector." patient condition reported, as fine.
Event or Problem Description
It was reported that: "leakage during ventilation at the taped connector." patient condition reported, as fine.
Additional Manufacturer Narrative
(b)(4), one representative sample of lot 21431 was returned for investigation.The visual examination of the originally packaged product showed no signs of contamination, discolorations or design irregularities.The graduation marks were clearly visible.The inspection of the white and yellow control balloons with mounted 2-way stop-cock and the connectors did not reveal any irregularities.An attempt was made to simulate the leakage.The pressure range on the digital manometer gmh 3111 with pressure sensor was set to various pressure values.An attachment was then fixed at the connector, the set pressure was applied, the tip area was squeezed, and the entire instrument was placed in a water bath and checked for leaks.Various back pressures were generated when sealing for the pressure test.The check took place in straight position of the tube and by bending the shaft end of the tube below the connector.A device history record (dhr) review was conducted on the reported lot 21431 and no issue that could have contributed to the reported event was identified.The error pattern could be simulated when applying different pressures/back pressures to the device.At an applied set value of 0.03 bar with back pressure of 0.10 bar - if the shaft of the tube is bent proximally below the connector by approx.20 to 30 degrees to the inner radius, isolated small air bubbles form in longer cycles.At an applied set value of 0.04 bar with back pressure of 0.13 bar - if the shaft of the tube is bent proximally below the connector by approx.20 to 30 degrees to the inner radius, small air bubbles escape permanently.At an applied set value of 0.05 bar with back pressure of 0.18 bar - if the shaft of the tube is bent proximally below the connector by approx.20 to 30 degrees to the inner radius, air bubbles escape permanently.The products are 100% checked several times during the manufacturing process for the tightness of the balloon system.The tightness of the material connection between the tube and the connector cannot be checked during production for manufacturing reasons.A manufacturing related issue could be identified.A non-conformance has been initiated to further investigate this issue.

• Brand Name: LASERTUBUS 6MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; 71394 kernen
• Manufacturer (Section G): TELEFLEX MEDICAL; willy-rusch-str. 4 - 10; 71394 kernen 71394 ; GM 71394
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15092667
• Report Number: 9610520-2022-00004
• Device Sequence Number: 14466929
• Product Code: BTR
• UDI-Device Identifier: 04026704002665
• UDI-Public: 04026704002665
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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
• Device Expiration Date: 09/30/2023
• Device Model Number: IPN040899
• Device Catalogue Number: 102004-000060
• Device Lot Number: 21431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/03/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown