FDA Adverse Event
Malfunction
Summary report: N
VENOUS BLOODLINE NON-MACHINE SPECIFIC
MDR report key: 233566
·
Received July 22, 1999
Report
- Report Number
- 8030665-1999-00221
- Event Type
- Malfunction
- Date Received
- July 22, 1999
- Date of Event
- May 20, 1999
- Report Date
- June 30, 1999
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FJK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CLINIC REPORTS DISCONNET FROM A FISTULA. ONE OF THREE DISCONNECT EVENTS (ONE FROM CATHETER AND ANOTHER FROM A FISTULA). CLINIC WAS RETRAINED AND NO FURTHER INCIDENCES HAVE OCCURRED. DON INDICATES THAT MORE FREQUENT CHECKING IS BEING PERFORMED. ALSO REFER TO PIR #9900940 AND 99001028. THE DISCONNECT RESULTED IN 100CC BLOOD LOSS AND MDR FILED DUE TO BLOODLOSS ONLY. 21-57 NO LOT NUMBER AND NO SAMPLE ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOODLINE NON-MACHINE SPECIFIC | BLOODLINE | FJK | ERIKA DE REYNOSA | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |