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

Catalog Number	5-16037
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2024, the tube balloon was found to be damaged.No more than 15 minutes after placement in patient, leakage of air was found.The device was replaced.There was no harm to the patient." associated complaints(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2024, the tube balloon was found to be damaged.No more than 15 minutes after placement in patient, leakage of air was found.The device was replaced.There was no harm to the patient." associated complaints 3003898360-2024-01164 and 3003898360-2024-01163.
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 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.The returned et tube was visually examined with and without magnification.Visual examination revealed that the sample appeared typical.Functional inspection identified a gap between the tube and the balloon cuff which caused the leak from the proximal end of the tracheal balloon cuff.A device history record review was performed, and no relevant findings were identified.The root cause of this issue is determined to be manufacturing related.Further investigation has been initiated under teleflex's quality system by the manufacturing site to evaluate this issue.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20265038
• Report Number: 3003898360-2024-01164
• Device Sequence Number: 8298285
• Product Code: CBI
• UDI-Device Identifier: 04026704397617
• UDI-Public: (01)04026704397617(11)200220(17)250219(10)73B2000353(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): 08/28/2024

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 Expiration Date: 02/19/2025
• Device Catalogue Number: 5-16037
• Device Lot Number: 73B2000353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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