MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. ADJ FLANGE NON LATEX NASA; AIRWAY, NASOPHARYNGEAL

Catalog Number	18542036
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the item itself is changing color.It should be green but some items have turned completely black, while others you can see them changing from green to black.The packaging is falling apart.None of these products have expired yet, but the packaging is ripping open and falling apart".Associated complaints 8040412-2025-00002, 8040412-2025-00003, 8040412-2025-00004 and 8040412-2025-00005.
Additional Manufacturer Narrative
(b)(4).Full udi not available as the lot # was not provided by the customer.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: from the sample reviewed, the product was found discoloured with brittle packaging.Apart from the tube and flange of product discoloured, the functionality still as intended.Packaging found brittle and yellow-ish.The device history record was reviewed and no issue that could have contributed to the re-ported failure was noted.The device passed 100% inspection and qa audit prior release.Based on the investigation, it is confirmed and verified that there is a failure as per reported.Sample were found discoloured.This failure will be address in non-conformance.Further investigation needs to be done to find the root cause of discoloration of product.
Event or Problem Description
It was reported that: "the item itself is changing color.It should be green but some items have turned completely black, while others you can see them changing from green to black.The packaging is falling apart.None of these products have expired yet, but the packaging is ripping open and falling apart".Associated complaints 8040412-2025-00002, 8040412-2025-00003, 8040412-2025-00004 and 8040412-2025-00005.

• Brand Name: ADJ FLANGE NON LATEX NASA
• Common Device Name: AIRWAY, NASOPHARYNGEAL
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21262780
• Report Number: 8040412-2025-00016
• Device Sequence Number: 9538533
• Product Code: BTQ
• UDI-Device Identifier: 14026704336194
• UDI-Public: (01)14026704336194(11)220528(17)270428(10)KMA22E0358(21)
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 18542036
• Device Lot Number: KMA22E0358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2022
• 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