MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, SHER-I-BRONCH, RS, 35 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Catalog Number	5-16135
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "6 oct 2024, the doctor found two blue balloon cuffs were leaking when doing testing before use on patient.Device was changed for a new one.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - balloon cuff" was confirmed based upon the investigation of the sample received.The customer returned one unit 5-16135 et tube, sher-i-bronch, rs, 35 fr for investigation.Visual examination of the returned device revealed no defects or anomalies.Functional inspection of the returned et tube revealed a hole in the distal bronchial (blue) balloon cuff which prevented the cuffs 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: "(b)(6) 2024, the doctor found two blue balloon cuffs were leaking when doing testing before use on patient.Device was changed for a new one." associated complaints 3003898360-2024-01375.

• Brand Name: ET TUBE, SHER-I-BRONCH, RS, 35 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• 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: 20558492
• Report Number: 3003898360-2024-01374
• Device Sequence Number: 11575938
• Product Code: CBI
• UDI-Device Identifier: 04026704397655
• UDI-Public: (01)04026704397655(11)240110(17)270528(10)73M2300731(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 5-16135
• Device Lot Number: 73M2300731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/13/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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