ADJ FLANGE NON LATEX NASA
Report
- Report Number
- 8040412-2025-00017
- Event Type
- Malfunction
- Date Received
- January 29, 2025
- Date of Event
- December 13, 2024
- Report Date
- January 6, 2025
- Manufacturer
- TELEFLEX MEDICAL SDN. BHD.
- Product Code
- BTQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). FULL UDI NOT AVAILABLE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER.
QN#(B)(4). FULL UDI NOT AVAILABLE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER. THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: FROM SAMPLE RECEIVED, THERE IS MOISTURE CONTAINED ON THE SURFACE OF PRODUCT EVEN PACKAGING SEALING IS IN GOOD CONDITION. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED, NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE IS NO FAILURE BASED ON THE FUNCTIONALITY BUT VISUAL THERE IS MOISTURE ON THE SURFACE OF PRODUCT. BASED ON THE INVESTIGATION, IT IS CONFIRMED AND VERIFIED THAT THERE IS A FAILURE AS PER REPORTED. MOISTURE INSIDE PACKAGING WERE FOUND DURING INVESTIGATION. CORRECTIVE AND PREVENTIVE ACTION HAD BEEN ADDRESSED FOR THIS ISSUE.
IT WAS REPORTED THAT: "CONDENSATION IN PACKAGING ON TUBE, DON'T SEE ANY PACKAGE DAMAGE". ASSOCIATED COMPLAINTS 8040412-2025-00002, 8 040412-2025-00003, 8040412-2025-00004 AND 8040412-2025-00005.
IT WAS REPORTED THAT: "CONDENSATION IN PACKAGING ON TUBE, DON'T SEE ANY PACKAGE DAMAGE". ASSOCIATED COMPLAINTS 8040412-2025-00002, 8 040412-2025-00003, 8040412-2025-00004 AND 8040412-2025-00005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 892424 | ADJ FLANGE NON LATEX NASA | AIRWAY, NASOPHARYNGEAL | BTQ | TELEFLEX MEDICAL SDN. BHD. | 20G21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |