FDA Adverse Event
Summary report: N
NORMAL SALINE FLUSH
MDR report key: 402778
·
Received June 25, 2002
Report
- Report Number
- MW4003306
- Date Received
- June 25, 2002
- Manufacturer
- BECTON DICKINSON AND CO
- Product Code
- FMF
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT ADMITTED TO LABOR AND DELIVERY UNIT FOR MGMT OF PREGNANCY ASSOCIATED HYPERTENSION. HAD IV LOCK IN PLACE. THE LOCK, NOT MAINTAINED WITH HEPARIN, WAS FLUSHED WITH A 10 ML PRESERVATIVE-FREE SYRINGE OF 0.9 SODIUM CHLORIDE, MFG BY BECTON DICKINSON. WITHIN 60 SECS OF FLUSHING THE LOCK THE PT SPONTANEOUSLY COMPLAINED OF A TERRIBLE TASTE IN THEIR MOUTH. THE BAD TASTE RESOLVED. SIMILAR REACTION OCCURRED IN THREE OTHER PTS ON SAME UNIT WITHIN 4 DAYS OF EACH OTHER. ALL PT'S SPONTANEOUSLY COMPLAINED OF SAME BAD TASTE WITHIN 60 SECS OF INJECTION. TWO PTS GOT BAD TASTE AFTER USING SYRINGES OF LOT 2032358 C. EXP 1/04, NDC 08290-0930-10. ALL SYRINGES OF THIS LOT REMOVED FROM UNIT. NO MORE COMPLAINTS ON UNIT IN 2 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NORMAL SALINE FLUSH | NORMAL SALINE FLUSH | FMF | BECTON DICKINSON AND CO | NA | 2032358C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |