FDA Adverse Event
Other
Summary report: N
VORTEX-DL-AC WITH KIT
MDR report key: 250818
·
Received November 19, 1999
Report
- Report Number
- 1056436-1999-00195
- Event Type
- Other
- Date Received
- November 19, 1999
- Date of Event
- October 4, 1999
- Report Date
- October 21, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 10/10/25/1999, THE DISTRIBUTOR INFORMED THE MANUFACTURER (MFR.) VIA A FAXED REPORT OF THE FOLLOWING: ON 10/21/1999, THE FACILITY'S PURCHASING AGENT INFORMED THE DISTRIBUTOR THAT PER THE CUSTOMER, "UNABLE TO ADVANCE THE CATHETER ON THE CHAMBER POST WITHOUT RUPTURING THE CATHETER." THE DISTRIBUTOR HAS ALREADY ISSUED A REPLACEMENT DEVICE TO THE FACILITY. THE DEVICE WAS SCHEDULED TO BE RETURNED TO THE MFR. FOR ANALYSIS. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VORTEX-DL-AC WITH KIT | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 981104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |