MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. SLICK SET UNCUFFED 3.0MM; TRACHEAL TUBE

Model Number	IPN914318
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "letters and marketing are coming off with tape".Unknown when issue was first identified.Unknown patient condition at time of report.Multiple attempts for additional information to the customer have been unsuccessful.
Event or Problem Description
It was reported "letters and marketing are coming off with tape".Unknown when issue was first identified.Unknown patient condition at time of report.Multiple attempts for additional information to the customer have been unsuccessful.
Additional Manufacturer Narrative
Qn#: (b)(4).No sample was returned for evaluation; therefore five representative samples were taken from production at the manufacturing facility and testing was conducted to determine the effects of chemicals (ipa, mek, mk72, hand gel, lidocaine) towards the tube markings.It was determined that the application of mek and mk72 could completely remove the tube markings.If the user is using one of these 2 chemicals the defect as mentioned could occur.The complaint could not be confirmed as no sample was returned.It is not known why the tubing marks would have been erased.There have been no changes in terms of ink composition and process at the manufacturing facility that could cause the ink to fade.It is advised that user should adhere to the precautions stated in the ifu.

• Brand Name: SLICK SET UNCUFFED 3.0MM
• Common Device Name: TRACHEAL TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12722062
• Report Number: 8040412-2021-00272
• Device Sequence Number: 4028357
• Product Code: BTR
• UDI-Device Identifier: 14026704644893
• UDI-Public: 14026704644893
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K780900
• 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): 10/07/2021

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 Model Number: IPN914318
• Device Catalogue Number: 170130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/29/2021
• 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.; N/A.
• Patient Sex: Unknown