FDA Adverse Event
Other
Summary report: N
MCGAW, INC.
MDR report key: 115144
·
Received August 15, 1997
Report
- Report Number
- 115144
- Event Type
- Other
- Date Received
- August 15, 1997
- Date of Event
- July 22, 1997
- Report Date
- August 6, 1997
- Manufacturer
- MCGAW, INC.
- Product Code
- FPB
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHILE ASSESSING PT'S LINES-FOUND TPN FILTER TO BE GRAY COLOR WITH BLACK FUZZY SUBSTANCE THROUGHOUT. CHANGED FILTER. ADVISED WHERE IT WAS FOUND. (RSC-TL STERILE PORT INFUSING D20, CENTRAL HYPERAL HAD RUN OUT EARLIER IN DAY) RSC-TL DISCONTINUED WITH C/S OF TID AND ICS DONE-AS WITH THE LIJ-ARROW INTRODUCER BEFORE IT WAS GUIDEWIRED TO A QL FOR INTRAVENOUS FLUID ACCESS. PT HAD BEEN SPIKING FEVERS TO 104 SINCE BEFORE 7P.M. PVP ISOLATOR, SPUTUM GRAM STAIN AND UA SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MCGAW, INC. | TPN FILTER | FPB | MCGAW, INC. | * | F7C285 OR F6L127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |