FDA Adverse Event
Injury
Summary report: N
MEDISYSTEMS ARTERIAL-VENOUS BLOOD TUBING
MDR report key: 55808
·
Received December 9, 1996
Report
- Report Number
- 9680437-1996-00006
- Event Type
- Injury
- Date Received
- December 9, 1996
- Report Date
- December 9, 1996
- Manufacturer
- MEDISYSTEMS CORPORATION
- Product Code
- FJK
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FACILITY REPORTS TWO INCIDENTS OF LEAKS. FACILITY REPORTS A LEAK IN THE BLOOD TUBING LINE DURING THE PT'S TREATMENT. ESTIMATED BLOOD LOSS 140-200 CCS. NO PT INJURY REPORTED. NO PT INJURY REPORTED IN EITHER INCIDENT. SEE PAGES 3-4 FOR OTHER PT'S INFO.
Description of Event or Problem · 2
FACILITY REPORTS A LEAK IN THE BLOOD TUBING LINE DURING THE PT'S TREATMENT. ESTIMATED BLOOD LOSS 140-200 CCS. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDISYSTEMS ARTERIAL-VENOUS BLOOD TUBING | ARTERIAL-VENOUS BLOOD TUBING FOR HEMODIALYSIS | FJK | MEDISYSTEMS CORPORATION | NA | 6724K3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | ||
| 2 | UNKNOWN | Other |