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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A verification of failure mode reported in the current manufacturing process was conducted as follows: 125 samples were taken from the current production from p/n 5-12614 et tube, cuffed, spiral-flex 7.0 lot# 73j2200526 the samples were visually inspected, and issue reported "labeling - wrong product/size in package" 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 package label info is inconsistent with product when clinical setting before using on patient at the same time.".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-12614 et tube, cuffed, spiral-flex 7.0 for investigation.The sample was returned sealed in its original packaging.Upon visual examination, it was confirmed that a size 7.5 et tube was returned instead of a size 7.0 that the package was labeled for.A capa has been previously opened by the manufacturing site to further investigate this type of issue.Corrective actions were implemented on 06may2022 and this sample was manufactured prior to these corrective actions.
Event or Problem Description
It was reported that: "the doctor found package label info is inconsistent with product when clinical setting before using on patient at the same time." no patient involvement.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15606765
• Report Number: 3003898360-2022-00612
• Device Sequence Number: 11296667
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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 Expiration Date: 06/13/2026
• Device Model Number: IPN048959
• Device Catalogue Number: 5-12614
• Device Lot Number: 73F2100433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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