FDA Adverse Event
Other
Summary report: N
CHEMO-PORT
MDR report key: 554988
·
Received November 11, 2004
Report
- Report Number
- 2925153-2004-00024
- Event Type
- Other
- Date Received
- November 11, 2004
- Report Date
- November 11, 2004
- Manufacturer
- HDC CORP.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RECEIVED DISTRIBUTOR'S E-MAIL IN 2004. IT READ, "PORT WAS DISCONNECTED." RECEIVED AN X-RAY 5 DAYS LATER SHOWING THE CATHETER BROKE OFF @ 1 INCH FROM CONNECTOR. HDC REQUESTED THREE TIMES FOR ADDITIONAL INFORMATION IN ORDER TO UNDERSTAND THE NATURE OF THE PROBLEM, BUT NO ADDITIONAL INFORMATION WAS PROVIDED YET. HDC IS SENDING INCOMPLETE REPORT NOW, IN ORDER TO COMPLY WITH MDR REPORT FILING DEADLINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHEMO-PORT | * | LJT | HDC CORP. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |