BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORMAL SALINE I.V. FLUSH SYRINGES

    MDR report key: 2721120 · Received August 27, 2012

    Report

    Report Number
    1423982-2012-00003
    Event Type
    Other
    Date Received
    August 27, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 24, 2012
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NGT
    PMA / PMN Number
    K091583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH LOT SAMPLES WERE PULLED FROM THE RETAIN ROOM FOR TESTING: ENDOTOXIN AND STERILITY TEST. ENDOTOXIN RESULT FOR BOTH LOT SAMPLES WERE NEGATIVE. STERILITY TEST REVIEW AT 48 HOURS SHOW NO GROWTH. BATCH RECORD REVIEW OF BOTH LOTS DID NOT REVEAL ANY ANOMALY LEADING TO THIS ISSUE. LAB RESULTS WERE WITHIN PARAMETERS WITH NO MICROBIOLOGICAL CONTAMINATION. THE PRODUCT IS FILTERED USING A DUAL CAPSULE FILTRATION (.45 MICRON/.22 MICRON) AND THEN TERMINAL STERILIZED. STERILITY TEST WILL CONTINUE FOR 14 DAYS. FOLLOW UP REPORT WILL BE FILED AT STERILITY TEST CONCLUSION. PRODUCT: NORMAL SALINE, PRESENTATION: 10 ML/12 ML SYRINGE, LOT NO. S12231, MFG DATE: 06/04/2012. EXPIR DATE: MAY 2014. NORMAL SALINE, 10 ML/12 ML SYRINGE, LOT NO. S12201, 04/23/2012, MARCH 2014.

    Description of Event or Problem · 1

    ON (B)(4) 2012, (B)(6) PHARMACY MGR, (B)(6), CONTACTED OUR FACILITY TO VERIFY IF WE HAVE ANY COMPLAINT ON A POSSIBLE CONTAMINATION OF NORMAL SALINE IV FLUSH. HE STATED THAT A PT WITH INTRACRANIAL ABSCESS WAS RECEIVING THE NORMAL SALINE IV FLUSH SYRINGES, 10 ML/12 ML SYRINGE FILL LOT NO. S12231 FOR MAINTENANCE OF THE GROSHONG CATHETER AND PRESENTED TO PHYSICIAN OFFICE WITH CHILLS AND FEVER. PT'S BLOOD WAS CULTURED AND DIAGNOSED WITH RALSTONIA PICKETTII. LATER ON (B)(6) CALLED AGAIN AND ASKED TO ALSO CHECK ON NORMAL SALINE IV FLUSH, LOT NO. S12201, EXP MARCH 2014, BECAUSE THE PT WAS TREATED WITH THIS OTHER LOT ABOUT A WEEK AGO. PT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORMAL SALINE I.V. FLUSH SYRINGES NORMAL SALINE I.V. FLUSHE SYRINGES NGT MEDEFIL, INC. NA SEE REMARKS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other NOT PROVIDED