MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, UNCUFFED, 2.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048902
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.From a picture provided from the customer, it was unable to be confirmed failure mode reported as "incorrect product shipped".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 use 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 and the samples were visually inspected, and issue reported "incorrect product shipped" 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
The customer reported that in the nicu they had an emergency and pulled a 2.5 trach tube (5-10405) and upon opening the package they found a 2.0.The reported defect was detected upon opening the device from packaging, prior to use in a clinical setting.Additional information reported no patient harm.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10405 et tube, uncuffed, 2.5 for investigation.The sample was returned with its original packaging, but the sample was opened.Upon visual examination, it was confirmed that a size 2.0 et tube was returned instead of a size 2.5 that the package was labeled for.Since the sample was returned open and out of its original packaging, it could not be confirmed that the incorrect size tube was in the package.Although this complaint could not be confirmed, a capa has been previously opened by the manufacturing site to further investigate this type of issue and to determine any corrective actions.
Event or Problem Description
The customer reported that in the nicu they had an emergency and pulled a 2.5 trach tube (5-10405) and upon opening the package they found a 2.0.The reported defect was detected upon opening the device from packaging, prior to use in a clinical setting.Additional information reported no patient harm.

• Brand Name: HUDSON ET TUBE, UNCUFFED, 2.5
• 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: 14597128
• Report Number: 3003898360-2022-00181
• Device Sequence Number: 5530295
• Product Code: BTR
• UDI-Device Identifier: 14026704616814
• UDI-Public: 14026704616814
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/11/2022

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: 08/10/2026
• Device Model Number: IPN048902
• Device Catalogue Number: 5-10405
• Device Lot Number: 73H2100392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Age: 1 MO
• Patient Sex: Female