BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEPARIN I.V. FLUSH SYRINGE

    MDR report key: 3312752 · Received March 20, 2013

    Report

    Report Number
    1423982-2013-00001
    Event Type
    Other
    Date Received
    March 20, 2013
    Date of Event
    October 22, 2012
    Report Date
    March 19, 2013
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NZW
    PMA / PMN Number
    K092491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT STATED THAT ONE SYRINGE TESTED WAS CONTAMINATED WITH THE PSEUDOMONAS PUTIDA. THIS COMPLAINT WAS ALREADY REPORTED TO MEDFIL, INC BY (B)(4) HEALTHCARE CENTER ON (B)(6) 2012. IT WAS FULLY INVESTIGATED, AND REPORTED TO THE FDA UNDER MDR NO. 1423982-2012-00005 ON (B)(4) 2012. TRIED SEVERAL TIMES TO CONTACT COMPLAINANT VIA PHONE CALLS AND E-MAILS. COMPLAINANT DID NOT RESPOND TO ANY OF THE FOLLOW UPS. EVEN THOUGH MEDEFIL, INC. DID NOT RECEIVE ADDITIONAL INFORMATION FOR THE COMPLETION OF THE COMPLAINT FILE AND REPORT, MEDEFIL CONTINUED WITH THE INVESTIGATION WHICH INCLUDED BATCH RECORD REVIEW AND STERILITY TESTING (14 DAYS PERIOD) OF THE RETAIN SAMPLE FROM SAME LOT. NO ADVERSE FINDINGS WERE ENCOUNTERED AND NO MICRO GROWTH WAS OBSERVED. ON (B)(4) 2013 WE CONTACTED MS. (B)(6), RISK MANAGER AT (B)(6) AND REQUESTED THE LAST SYRINGE THEY HAVE FROM SAME LOT FOR TESTING. A FOLLOW UP REPORT WILL BE FILED WITH FDA ONCE SAMPLE IS RECEIVED AND TESTED. MS. (B)(6) ALSO CONTACTED TO THE MANUFACTURER OF NORMAL SALINE (CONCOMITANT PRODUCT) FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, WE RECEIVED FROM (B)(4) A MEDWATCH UF/IMPORTER REPORT# (B)(4), REPORTED BY MS. (B)(6) THAT PATIENT CAME IN FOR PORT FLUSH. PORT WAS ACCESSED AND BLOOD RETURNED. PORT FLUSHED. PATIENT BECAME SHORT OF BREATH AND COMPLAINED OF BACK PAIN. SENT TO ED AND ADMITTED FOR PULMONARY EMBOLUS AN FEVER. ANTIBIOTICS ADMINISTERED. PORT REMOVED AND FLUSHED. FLUID OBTAINED FROM PORT GREW PSEUDOMONAS PUTIDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116857 HEPARIN I.V. FLUSH SYRINGE HEPARIN I.V. FLUSH SYRINGE NZW MEDEFIL, INC. NA H112121N

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other NORMAL SALINE FLUSH, BECTON AND DICKINSON