FDA Adverse Event
Other
Summary report: N
FILTERFLOW
MDR report key: 615313
·
Received June 16, 2005
Report
- Report Number
- 2647836-2005-00002
- Event Type
- Other
- Date Received
- June 16, 2005
- Date of Event
- April 23, 2005
- Report Date
- May 25, 2005
- Manufacturer
- B. BRAUN MEDICAL , INC.
- Product Code
- FPB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY ON THE MEDWATCH FORM: IV FILTER TUBING DISCONNECTED AT THE FILTER AND WAS FOUND ON THE PATIENT'S FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILTERFLOW | SMALLBORE FILTERED EXTENSION SET | FPB | B. BRAUN MEDICAL , INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 MO | Other| R |