MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH NASORAL UNCUFF MURPHY ET 3.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN040775
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Complaint reports that: "it is reported that no marks printed in the tube is identified for adequate placement.".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was not returned for evaluation; therefore, 5 representative samples were taken from current production at the manufacturing facility.A visual exam was performed and all markings were legible.Testing was conducted to determine the effects of chemicals towards the tube markings.It was determined that the application of mek and mk72 could completely remove the tube markings.In the absence of a sample, the complaint of tube markings erased could not be confirmed.There is 100% visual inspection conducted at the manufacturing facility; therefore, any defects of this type would be detected prior to release.In addition, the product has exceeded the expiration date.
Event or Problem Description
Complaint reports that: "it is reported that no marks printed in the tube is identified for adequate placement".

• Brand Name: RUSCH NASORAL UNCUFF MURPHY ET 3.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• 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 ; 9193614124
• MDR Report Key: 15292121
• Report Number: 8040412-2022-00237
• Device Sequence Number: 2504724
• Product Code: BTR
• UDI-Device Identifier: 14026704340795
• UDI-Public: 14026704340795
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K961840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 05/31/2022
• Device Model Number: IPN040775
• Device Catalogue Number: 100382030
• Device Lot Number: 17FE25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/23/2022
• 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
• Patient Sex: Unknown