MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN ET TUBE, SHER-I-BRONCH, RS, 37 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Catalog Number	5-16137
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one, no impact on patient".No patient involvement.
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: corrected data:.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - balloon cuff" could not be confirmed based upon the sample received.The customer returned one unit 5-16137 et tube, sher-i-bronch, rs, 37 fr for investigation.The et tube was returned with its stylet.The et tube was visually examined with and without magnification.Visual examination of the returned sample revealed that the et tube appears used as there was biological material present on the device.No other defects or anomalies were observed.A functional inspection was performed to attempt to inflate and deflate the balloon cuffs on the returned et tube.A syringe was filled with air and attached to the valve of the tracheal (white) pilot balloon.Upon injection of air, both the pilot balloon and cuff immediately inflated.The same process was used to test the bronchial (blue) inflation line.Once again, both the pilot balloon and cuff immediately inflated.The syringe was then removed, and the cuffs and pilot balloons were inspected for leaks.No leaks were detected.The syringe was then reattached in order to deflate the balloons.All pilot balloons and balloon cuffs were able to deflate.The et tube was submerged underwater and an attempt to inflate the balloon cuffs was made to detect any leaks.Upon injection of air, no leaks were detected.No functional issues were found with the returned sample.The ifu for this product 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." a device history record review was performed, and no relevant findings were identified.The returned et tube was able to inflate and deflate with no difficulty.All et tubes are 100% inspected for both inflation and deflation at the time of manufacturing.No functional issues were found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one, no impact on patient".No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).In section d provided the full udi #.Additionally added the brand name of the device.**udi related data quality updates only**.
Event or Problem Description
It was reported that "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one, no impact on patient".No patient involvement.

• Brand Name: SHERIDAN ET TUBE, SHER-I-BRONCH, RS, 37 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18011713
• Report Number: 3003898360-2023-01447
• Device Sequence Number: 7469269
• Product Code: CBI
• UDI-Device Identifier: 04026704397662
• UDI-Public: (01)04026704397662(11)190925(17)240924(10)73J1900414(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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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 Expiration Date: 09/24/2024
• Device Catalogue Number: 5-16137
• Device Lot Number: 73J1900414
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/28/2023; Not provided
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/29/2023; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• 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.; N/A.
• Patient Sex: Unknown