BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPARIN IV FLUSH SYRINGE

    MDR report key: 4232615 · Received November 6, 2014

    Report

    Report Number
    1423982-2014-00001
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 4, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NZW
    PMA / PMN Number
    K092491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SYRINGE WAS NOT USED ON A PATIENT. REVIEW OF THE BATCH RECORD FOR THIS LOT REVEALED NO INCIDENT IN THE MANUFACTURING OF THIS LOT. THIS IS AN ISOLATED EVENT SINCE THERE HAVE BEEN NO COMPLAINTS RECEIVED FOR THIS EVENT. THE COMPLAINT INVESTIGATION DISCLOSED THAT THE RETAIN SAMPLES REVEALED THAT NO SYRINGES WERE FOUND WITH ANY DEFECT. THE CAPA IS ALREADY OPEN FOR INVESTIGATING THIS ISSUE INTERNALLY. THEREFORE WE ARE CLOSING THIS COMPLAINT AND THE FURTHER INVESTIGATION WILL BE COVERED AND RECORDED UNDER CAPA. THIS IS AN ISOLATED EVENT. THE COMPLAINANT HAS NO ADDITIONAL CONCERNS OR MORE INFORMATION REGARDING THIS EVENT. BASED ON THIS INFORMATION, WE WILL BE CLOSING THIS COMPLAINT. HOWEVER, THIS ISSUE WILL BE FURTHER HANDLED AND INVESTIGATED WITHIN THE MEDEFIL QUALITY MANAGEMENT SYSTEM.

    Description of Event or Problem · 1

    ON (B)(4) 2014, MEDEFIL, INC., RECEIVED A LETTER FROM FDA DATED SEPTEMBER 30, 2014 REGARDING THE FOLLOWING COMPLAINT. (B)(4). PRODUCT: HEPARIN IV FLUSH SYRINGE, 100UNITS. FILL VOLUME: 5ML IN 12ML SYRINGE. LOT NUMBER: H114337N. EXPIRY DATE: 05/31/2016. COMPLAINANT (B)(6) , PHARMACY MANAGER AT (B)(6) , STATED IN THE LETTER THAT "...PREFILLED SYRINGE PLUNGER SIGNIFICANTLY CRACKED, AND CLINICIAN UNABLE TO DELIVER MEDICATION"... (B)(6) 2014, 9:39AM: (B)(6) , DIRECTOR OF REGULATORY AFFAIRS AT (B)(6) , RECEIVED A RETURNED CALL FROM (B)(6), CERTIFIED PHARMACY TECHNICIAN AT (B)(6) . (B)(6) , WHO REPORTS TO (B)(6) , STATED THAT "... THE NURSES HAD TRIED USING 10 TO 11 SYRINGES OF THIS ONE LOT (BOX OF SIXTY SYRINGES) AND ALL WERE UNUSABLE, CRACKED PLUNGERS, "FLIMSIER" THAN PREVIOUS SYRINGES RECEIVED FROM MEDEFIL, INC ... ". ACCORDING TO (B)(6) , THIS WAS THE ONLY BOX WITH THIS LOT# IN THEIR POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714729 HEPARIN IV FLUSH SYRINGE HEPARIN IV FLUSH SYRINGE NZW MEDEFIL, INC. NA H114337N

    Patients

    Seq Age Sex Outcome Treatment
    1