FDA Adverse Event
Malfunction
Summary report: N
TRIUMPH-1 PORT
MDR report key: 212344
·
Received March 2, 1999
Report
- Report Number
- 1056436-1999-00030
- Event Type
- Malfunction
- Date Received
- March 2, 1999
- Date of Event
- January 22, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
ON 02/01/1999, THE MFR REC'D MEDWATCH REPORT THAT STATES THE FOLLOWING: UNABLE TO ACCESS THE DEVICE. PRESENTED TO ANGIO FOR RETRIEVAL AND REPLACEMENT. THE DEVICE WAS REMOVED FROM THE CHEST AND ON INSPECTION DEMONSTRATED THAT THE CATHETER HAD FRACTURED APPROXIMATELY 2CM FROM THE JUNCTION OF THE DEVICE. THE REPORT ALSO STATES THAT THERE WAS NO ADVERSE OUTCOME AS A RESULT OF THIS EVENT. 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. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |