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

Catalog Number	18542032
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Full udi not available as the udi# was not provided by the customer.
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).The actual complaint device was not returned; however, the customer provided a photo for evaluation.Based on the review of the photo, the complaint was confirmed.The manufacturing site reports a capa has been opened to address this issue.
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) lot number of the device identified as kma22a0318.A device history record review was performed on lot# kma22a0318 and no relevant findings were identified.Section d.4.-udi# corrected to (b)(4).
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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21263367
• Report Number: 8040412-2025-00018
• Device Sequence Number: 19901921
• Product Code: BTQ
• UDI-Device Identifier: 14026704336170
• UDI-Public: (01)14026704336170(11)220128(17)261228(10)KMA22A0318(21)
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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,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: 18542032
• Device Lot Number: KMA22A0318
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 03/04/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/20/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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