FDA Adverse Event
Other
Summary report: N
INSERTION TRAY
MDR report key: 281811
·
Received June 13, 2000
Report
- Report Number
- 1056436-2000-00114
- Event Type
- Other
- Date Received
- June 13, 2000
- Date of Event
- May 13, 2000
- Report Date
- May 17, 2000
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- KOC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IN 2000, THE FACILITY'S NURSE, MANAGER INFORMED THE MFR'S (MFR.) SALES REPRESENTATIVE OF THE FOLLOWING: THE NURSE FLUSHED THE CATHETER WITH SALINE. NURSE THEN ASPIRATED BLOOD THROUGH THE CATHETER AND NOTICED A SMALL PINHOLE APPROXIMATELY 2 CM ABOVE THE Y-HUB CONNECTION ON THE SILICONE EXTENSION. BLOOD LEAKED OUT OF THE SMALL HOLE AND AS A RESULT, THE PHYSICIAN REMOVED THE DEVICE. THE DEVICE IS 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 | INSERTION TRAY | ACUTE POLYURETHANE CATHETER | KOC | NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other |