MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10315
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "union had a teleflex failure issue last night and was reported to safety net after the event.The failure resulted in the patient having to be reintubated." additional information: "the patient had to be re-intubated which caused a delay to treatment but there was no other harm or consequence to the patient.There was no desaturation.".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - device leak - cuff" was confirmed based upon the sample received.The customer returned one unit 5-10315 et tube, hvt,7.5 for investigation.Visual examination of the returned device revealed that the sample appeared used as there was biological material present on the device.Functional inspection of the returned device revealed multiple small holes in the balloon cuff which prevented it from being able to stay inflated.A review of the manufacturing process confirmed that all et tubes undergo 100% inspection for inflation and deflation, as part of the product release criteria.Any such defects would be detected as out of specification.The nature of the damage suggests it was not caused by a manufacturing process failure.A device history record review was performed, and no relevant findings were identified.Additionally, the ifu states, "care should be taken to avoid damaging the cuffs during intubation.If any one of the cuffs is damaged, the tube should not be used." "cuff pressure should be monitored routinely to assure that an adequate seal is maintained and that the cuffs have not become over-inflated." "deflate all cuffs prior to repositioning the tube.Movement of the tube with cuffs inflated could result in patient injury or in damage to the cuffs, requiring a tube change.Verify the position of the tube after each repositioning." based upon the damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "union had a teleflex failure issue last night and was reported to safety net after the event.The failure resulted in the patient having to be reintubated.".Additional information: "the patient had to be re-intubated which caused a delay to treatment but there was no other harm or consequence to the patient.There was no desaturation.".

• Brand Name: ET TUBE, HVT, 7.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20566841
• Report Number: 3003898360-2024-01380
• Device Sequence Number: 7816828
• Product Code: BTR
• UDI-Device Identifier: 04026704397044
• UDI-Public: (01)04026704397044(11)231218(17)281216(10)73M2300480(21)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 5-10315
• Device Lot Number: 73M2300480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown