FDA Adverse Event Injury Summary report: N

TYCO HEALTHCARE 100 UNITS/ ML

MDR report key: 1029632 · Received April 12, 2008

Report

Report Number
MW5006245
Event Type
Injury
Date Received
April 12, 2008
Date of Event
April 5, 2008
Report Date
April 12, 2008
Manufacturer
TYCO HEALTHCARE GROUP
Product Code
NZW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NH, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE BEEN USING A HEPARIN FLUSH FOR MY PICC LINE SINCE 2008. THE LOCAL VNA WAS OBTAINING THE PRODUCT FOR HOME USE. ON THE SAME MONTH, I RECEIVED A CALL FROM THE PHARMACIST AT HME AND IV, AND SO NH INDICATING THAT THE HEPARIN FLUSH I WAS USING WAS RECALLED, THOUGH I HAD NO ILL REACTION. THEY WANTED TO COME TO GET THE RECALLED HEPARIN AND REPLACE IT WITH ANOTHER HEPARIN FLUSH. ON THAT SAME DAY, THEY EXCHANGED THE HEPARIN WITH ONE FROM TYCO HEALTHCARE KENDALL. LOT 8010124. I BEGAN USING IT AND BY TWO DAYS LATER, I WAS HAVING LOW BLOOD PRESSURE 90/58, NAUSEA, VOMITING AND SEVERE STOMACH PAIN. I CALLED THE VNA AND MY DOCTOR AND WAS TOLD THERE WAS A GASTRIC THING GOING AROUND. SO, I JUST TOOK MAALOX, BUT CONTINUED TO HAVE THE SAME SYMPTOMS. ON THE NEXT DAY, THE SYMPTOMS CONTINUED AND CONSIDERED GOING TO THE ER. AGAIN I CALLED THE VNA AND MY PCP, BUT HAD ALSO DONE SOME RESEARCH ABOUT THE HEPARIN RECALL BECAUSE I WONDERED WHY IT HAD BEEN RECALLED. I SAW THAT MY SYMPTOMS MATCHED THE ONES MENTIONED IN THE RECALL. ONCE I SHARED THIS, IT WAS DETERMINED THAT I WOULD STOP THE TWO HEPARIN FLUSHES DAILY AND INSTEAD DO THREE SALINE FLUSHES DAILY, AND WE WOULD LOOK AT IT AGAIN ON THE FOLLOWING DAY. AFTER VOMITING PROFUSELY THE PREVIOUS NIGHT, I WAS ABLE TO FINALLY FALL ASLEEP. ON THE NEXT DAY, I BEGAN TO FEEL BETTER 85% AND BY THREE DAYS LATER, THE SEVERE STOMACH PAIN WAS COMPLETELY GONE. I CONTACTED KENDALL BY EMAIL, BUT HAVE RECEIVED NO RESPONSE. THAT IS WHY I AM NOW WRITING TO YOU. I SEE THAT KENDALL RECALL LOTS 8010114 AND 8010134 BUT NOT MINE 8010124. SINCE I HAD WHAT I WOULD CALL A REACTION TO THE HEPARIN AS NOTED IN WHAT I'VE READ ONLINE, I REQUEST THAT MY LOT ALSO BE CHECKED AND RECALLED IF NECESSARY. THANK YOU FOR YOUR ANTICIPATED QUICK RESPONSE. DOSE OR AMOUNT: ONE SYRINGE. FREQUENCY: TWICE DAILY FOR EACH. ROUTE: IV. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: FLUSH PICC LINE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TYCO HEALTHCARE 100 UNITS/ ML HEPARIN LOCK FLUSH SYRINGE NZW TYCO HEALTHCARE GROUP 8881590125 8010124
2 KENDALL 5ML IN 12 ML HEPARIN LOCK FLUSH SYRINGE NZW KENDALL 8881590125 8010124

Patients

Seq Age Sex Outcome Treatment
1 Other