BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEP LOCK FLUSH FT 30

    MDR report key: 1593833 · Received February 2, 2010

    Report

    Report Number
    1021343-2010-00013
    Event Type
    Other
    Date Received
    February 2, 2010
    Date of Event
    January 4, 2008
    Report Date
    January 22, 2010
    Manufacturer
    HOSPIRA INC.
    Product Code
    NZW
    PMA / PMN Number
    K005264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    DOCUMENT RECEIVED ALLEGES AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. THIS IS A COMBINATION PRODUCT THAT IS BEING REPORTED FOR THE DRUG PORTION OF THE PRODUCT. IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL FOR AN OMENTECTOMY AND TUBE COLOSTOMY. WHILE HOSPITALIZED, THE PT RECEIVED AN UNSPECIFIED VOLUME OF HEPARIN LOCK FLUSH SOLUTION USP 100 UNITS/ML (EXP DATE: 03/01/2009) FOR AN UNSPECIFIED INDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. IT WAS NOT REPORTED IF ANY MEDICAL INTERVENTION WAS REQUIRED OR IF THE PT RECOVERED FROM THE UNSPECIFIED ADVERSE EVENT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEP LOCK FLUSH FT 30 80NGT NZW HOSPIRA INC. NA 57322DK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other MULTITRACE| NEURONTIN| POTASSIUM CHLORIDE| VERSED| MORPHINE| FAMOTIDINE| FLAGYL| VICODIN| SODIUM CHLORIDE INJECTION| CALCIUM GLUCONATE| TORADOL| MORPHINE| PROTONIX| AVELOX| WARFARIN| DIFLUCAN| PROMETHAZINE| TRAVASOL| DEXTROSE| INTRALIPID| MAGNESIUM SULFATE| SODIUM PHOSPHATE MONOBASIC| MVI| ZOFRAN| SPIRONOLACTONE| LASIX| METOCLOPRAMIDE| LIDOCAINE| FENTANYL| VITAMIN K1| LEVAQUIN| REGAL| PERCOCET (DOSAGES AND MFR ARE UNK)| BELLADONNA EXTRACT| CIMETIDINE