FDA Adverse Event
Malfunction
Summary report: N
TRIUMPH-1 PORT
MDR report key: 275240
·
Received April 27, 2000
Report
- Report Number
- 1056436-2000-00080
- Event Type
- Malfunction
- Date Received
- April 27, 2000
- Date of Event
- March 17, 2000
- Report Date
- March 31, 2000
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 03/31/2000, THE FACILITY'S MATERIALS MGR INFORMED THE MANUFACTURER'S (MFR.) REPRESENTATIVE OF THE FOLLOWING: TWO (2) PIECES CAME APART AND THEY ARE NOT SUPPOSE TO. WHEN ASKED WHAT EXACTLY CAME APART, THE DEVICE BODY, THE CATHETER, MGR REPLIED THAT MGR WAS NOT A CLINICIAN AND DID NOT KNOW. THE MFR'S REPRESENTATIVE ASKED IF IT WAS THE DEVICE BODY (ROUND DISK) OR THE TUBING/CATHETER ETC. MGR HAD TWO (2) PIECES OF "CATHETER." WHEN ASKED IF THE DEVICE WAS IMPLANTED, MGR STATED THAT TO MGR'S KNOWLEDGE, IT HAD NOT BEEN IMPLANTED. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIUMPH-1 PORT | VASCULAR ACCESS PORT | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |