FDA Adverse Event
Injury
Summary report: N
HEPARIN FLUSH 100 UNITS/ML
MDR report key: 1081417
·
Received July 23, 2008
Report
- Report Number
- MW5007790
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 23, 2008
- Manufacturer
- AM USA - AMSINO MEDICAL
- Product Code
- NZW
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ABOUT 90 MINS AFTER USING A 100 UNIT HEPARIN FLUSH I SUDDENLY STARTED TO SHAKE VIOLENTLY, GET BURNING HOT, AND CHILLS, NAUSEA AND MY BLOOD PRESSURE WAS ABOUT 90/38 FOR AN EXTENDED TIME. I HAD TO CALL 911 AND WAS TAKEN TO HOSPITAL. BLOOD TESTS AND URINALYSIS WERE DONE, BUT NO EXPLANATION FOR THE EVENT WAS DETERMINED. I ALSO TAKE CUBICIN FOR DISCITIS, BUT THE LAST DOSE HAD BEEN ALMOST 20 HRS EARLIER. DOSE OR AMOUNT: 2 DOSES 3ML, FREQUENCY: 2 TIMES A DAY, ROUTE: IV. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: FLUSHING IV TUBE. EVENT REAPPEARED AFTER REINTRODUCTION? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEPARIN FLUSH 100 UNITS/ML | NONE | NZW | AM USA - AMSINO MEDICAL | KH02775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | SINGLE DOSE SYRINGE| SODIUM CHLORIDE FLUSH SYRINGE| CUBICIN 500 MG |