MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN048997
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer provided photos that confirmed the defect reported by the customer "broken/cracked - double swivel connector".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.Part number reported is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 80 samples were taken from the current production from p/n 5-16037 et tube, sher-i-bronch, ls, 37 fr lot# 73e2200696 the samples were visually inspected and issue reported "broken/cracked - double swivel connector" was not observed in the current manufacturing process.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Customer reported that the connecting points of the accessory piece has been snapping off while in use.The reported defect was detected during use on patient.The patient condition was reported as "fine." no patient injury/consequence or medical intervention reported.

• Brand Name: HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14654068
• Report Number: 3003898360-2022-00221
• Device Sequence Number: 4918874
• Product Code: CBI
• UDI-Device Identifier: 14026704617415
• UDI-Public: 14026704617415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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
• Device Model Number: IPN048997
• Device Catalogue Number: 5-16039
• Device Lot Number: 73C2100552
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.
• Patient Sex: Unknown