MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, CUFFED, SPIRAL-FLEX 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048959
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Part number reported, 5-12614 et tube, cuffed, spiral-flex 7.0, is not being manufactured currently, however, another part number from the same family (p/n 5-10315 l/n 73l2100123) was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: (b)(4) samples were taken from the current production; the samples were visually inspected and issue reported "broken/cracked - pilot balloon/valve" 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
It was reported that "the doctor found balloon broken when doing inflation during clinical setting before using on patient".No patient involvement reported.

• Brand Name: HUDSON ET TUBE, CUFFED, SPIRAL-FLEX 7.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• 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: 12908239
• Report Number: 3003898360-2021-01051
• Device Sequence Number: 20040889
• Product Code: BTR
• UDI-Device Identifier: 14026704617071
• UDI-Public: 14026704617071
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K844296
• 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
• Report Date (Section B): 11/08/2021

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 Expiration Date: 02/11/2025
• Device Model Number: IPN048959
• Device Catalogue Number: 5-12614
• Device Lot Number: 73B2000277
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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