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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2024, the doctor found blue balloon cuff leakage when doing testing before using on patient.".
Event or Problem Description
It was reported that: "(b)(6) 2024, the doctor found blue balloon cuff leakage when doing testing before using on patient.".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-16135 et tube, sher-i-bronch, rs, 35 fr for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appeared typical.No defects or anomalies were observed.Functional inspection was performed to attempt to inflate and deflate the balloon cuffs on the returned et tube.A lab inventory syringe was filled with air.First, the syringe was connected to the bronchial (blue) pilot balloon.Using hand pressure, air was injected through the valve.Upon injection of air, the balloon cuffs were unable to inflate.Next, the tracheal (white) inflation line was tested.Upon injection of the air, the balloon cuff was able to properly inflate.The syringe was reconnected to the tracheal inflation line and the cuff was able to properly deflate as well.The device was sub-merged underwater to detect any leaks.Upon injection of air, the bronchial balloon cuffs leaked from a hole in the distal cuff.No other defects or anomalies were o bserved.Device history review investigation did not show issues related to complaint.The ifu states, "the cuff inflation system (cuffs, pilot balloons, valves) should be checked by inflation and deflation prior to use.If cuff is damaged, the tube should not be used.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." the reported complaint of "leak - balloon cuff" was confirmed based upon the sample received.The returned et tube was found to have a hole in the distal bronchial (blue) balloon cuff which prevented the cuffs from being able to stay inflated.A device history record review was per-formed with no evidence to suggest a manufacturing related cause.All et tubes are 100 percent inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20663582
• Report Number: 3003898360-2024-01419
• Device Sequence Number: 7371852
• Product Code: CBI
• UDI-Device Identifier: 04026704397655
• UDI-Public: (01)04026704397655(11)240216(17)270528(10)73B2400503(21)
• Combination Product (Y/N): N
• 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): 10/18/2024

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: 73B2400503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown