BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN I.V. FLUSH SYRINGE, 100 UNITS/ML

    MDR report key: 1033403 · Received April 23, 2008

    Report

    Report Number
    MW5006379
    Event Type
    Injury
    Date Received
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDEFIL
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CHS HAS PROVIDED HEPARIN FOR PT FOR LINE MAINTENANCE. CHS PHARMACY WAS NOTIFIED OF A VOLUNTARY RECALL OF THE PRODUCT THAT HAD BEEN DISPENSED TO PT. PATIENT RECEIVED SYRINGES FROM THE RECALLED LOTS ON THREE DAYS OF 2008. A PHARMACIST CALLED PT'S MOM ON 04/10/2008 TO INFORM OF THE RECALL AND MAKE ARRANGEMENTS TO PROVIDE A REPLACEMENT PRODUCT. PER OUR RECALL LETTER, THIS PHARMACIST INFORMED MOM THAT SOME PATIENTS RECEIVING HEPARIN HAD EXPERIENCED SHORTNESS OF BREATH, NAUSEA, VOMITING, ABDOMINAL PAIN AND LOW BLOOD PRESSURE. ALSO, MOTHER WAS INFORMED THAT NO PT'S RECEIVING THE MEDEFIL PRODUCT HAD ANY ADVERSE REPORTS AND THAT THE MEDEFIL RECALL IS VOLUNTARY BY THE CO. MOM STATED, THAT PT DOES HAVE NAUSEA, VOMITING, AND ABDOMINAL PAIN. SHE STATED, THAT PT HAS AN APPOINTMENT IN THE HEME/ONC CLINIC IN 2008. INSTRUCTED MOM TO INFORM PHYSICIAN OF HER CONCERNS. DOSE OR AMOUNT: 3 ML, FREQUENCY: ONCE DAILY, ROUTE: IV. DATES OF USE: ONE DAY IN 2008. DIAGNOSIS OR REASON FOR USE: LINE MAINTENANCE OF TPN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN I.V. FLUSH SYRINGE, 100 UNITS/ML NONE NZW MEDEFIL H107332

    Patients

    Seq Age Sex Outcome Treatment
    1 MVI-PEDIATRIC 5ML EVE4RY 48 HOURS| ALBUTEROL 90MCG AEROSOL EVERY 46 HOURS AS NEEDED| SODIUM CHLORIDE 0.9%| DIFLUCAN 150MG TAB DAILY| MIRALAX 3350 NF POWDER DAILY| INTRALIPID 20% EVERY 48 HOURS| TPN 2-IN-1 EVERY 48 HOURS| ALLOPURINOL 100MG TAB THREE TIMES DAILY| ZOFRAN 4MG TAB EVERY 8 HRS| NEURONTIN 100MG CAP TWICE DAILY| NEUPOGEN 300MCG INJ DAILY| PREVACID 30MG STB TAB DAILY| PREDNISONE 5MG/5ML SOLUTION THREE TIMES DAILY| LOPERAMIDE 2MG TAB EVERY 12 HOURS| SIMETHICONE 40/0.6ML EVERY 6 HOURS| ACIDOPHILUS LACTOBACILLUS POWDER EVERY 12 HOURS| TYLENOL/CODEINE #3 TAB EVERY 4 HOURS AS NEEDED| PENTAMIDINE 300MG INJ EVERY MONTH| ATARAX 10MG/5ML SYP EVERY 6-8 HOURS AS NEEDED| COLACE 100MG CAP DAILY| ZANTAC 150 MG CAPSULE TWICE DAILY| MAALOX SUSPENSION EVERY 6 HOURS