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

Catalog Number	5-16137
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that "27 aug 2024, damaged to the product's outer packaging.This product was opened from the carton and found that the paper-plastic packaging was not fully closed and there was a large opening.".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "incomplete seal - sterility compromised" could not be confirmed upon investigation of the returned sample.The customer returned one unit 5-16137 et tube, sher-i-bronch, rs, 37 fr for investigation.The et tube, two suction catheters, both swivel connectors, and the y connector were all returned in their original packaging.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the ett package was partially opened.No issues were found with the integrity of the sterile barrier on the packaging.The manufacturing site confirmed that the package did not present any blemishes or abnormalities in the sterile barrier.The sterile barrier appears to be fully intact.A review of the manufacturing process confirmed that a burst test is performed at the time of manufacturing to help prevent this type of issue from occurring.A device history record review performed on the stylet did not reveal any manufacturing related issues.Based on the condition of the returned sample, there is no evidence to suggest a manufacturing related root cause.It could not be determined how or when the package was opened.Teleflex will continue to monitor and trend on this issue.
Event or Problem Description
It was reported that, "on (b)(6) 2024, damaged to the product's outer packaging.This product was opened from the carton and found that the paper-plastic packaging was not fully closed and there was a large opening.".

• Brand Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20265429
• Report Number: 3003898360-2024-01204
• Device Sequence Number: 12852982
• Product Code: CBI
• UDI-Device Identifier: 04026704397662
• UDI-Public: (01)04026704397662(11)200617(17)250616(10)73F2000240(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): 09/11/2024

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 Expiration Date: 06/16/2025
• Device Catalogue Number: 5-16137
• Device Lot Number: 73F2000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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
• Patient Sex: Unknown