MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, HVT, 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048895
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.From the pictures attached it was confirmed the defect reported by the customer "foreign material - other".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.5-10314 et tube, hvt, 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 "foreign material - other" 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 "[a] piece of plastic [was] found inside endotracheal tube".No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one sample from unit 5-10314 et tube, hvt, 7.0 for investigation.The et tube was not returned, but the packaging was returned with a piece of material taped to it.The material was visually examined with and without magnification.Visual examination revealed that the material was the piece of tubing that was cut off to make the murphy eye on the distal end of the tube.This was the reported foreign material that was found inside of the et tube.A non-conformance has been opened at the manufacturing site to further investigate this issue.
Event or Problem Description
It was reported "[a] piece of plastic [was] found inside endotracheal tube".No patient involvement reported.

• Brand Name: HUDSON ET TUBE, HVT, 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12868526
• Report Number: 3003898360-2021-01058
• Device Sequence Number: 3459090
• Product Code: BTR
• UDI-Device Identifier: 14026704616746
• UDI-Public: 14026704616746
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 06/28/2026
• Device Model Number: IPN048895
• Device Catalogue Number: 5-10314
• Device Lot Number: 73F2100925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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