BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMSINO MEDICAL USA

    MDR report key: 2526520 · Received May 20, 2009

    Report

    Report Number
    1057300-2009-00001
    Event Type
    Other
    Date Received
    May 20, 2009
    Date of Event
    May 12, 2009
    Report Date
    May 19, 2009
    Manufacturer
    AMSINO MEDICAL USA
    Product Code
    FOZ
    PMA / PMN Number
    K984590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND COMPLAINT AMSINO MEDICAL USA HAS RECEIVED REGARDING A BROKEN LUERLOCK OFF THE SYRINGE. THE FIRST COMPLAINT ((B)(4)) WAS RECEIVED ON (B)(4) 2009. THE INCIDENT OCCURRED ON (B)(6) 2009. THERE WAS NO ADVERSE EVENT OR ACTION REQUIRED. LUERLOCK BROKE OFF IN CATHETER WHILE TRYING TO FLUSH A LINE. LOT #: KH03056, CODE (B)(4). AFTER RECEIVING THE 2ND COMPLAINT ON (B)(4) 2009 (THIS MEDWATCH REPORTABLE), AMSINO MEDICAL USA INVESTIGATED THE COMPONENT SOURCING OF THE SYRINGES (AMSINO PURCHASES SYRINGES) AND FOUND ONE COMMON LOT FOR BOTH AMSINO MEDICAL USA PRE-FILLED SYRINGE LOTS. THE COMMON LOT FROM OUR SUPPLIER: 90610228, ITEM # (B)(4). AMSINO HAS NOTIFIED COVIDIEN AND BEEN TOLD THAT A BATCH REVIEW IS TAKING PLACE. HOWEVER AT THE TIME OF THIS REPORT ((B)(4) 2009) NO INFO HAS BEEN RECEIVED BACK REGARDING COVIDIEN'S LOT # 906100228. AMSINO'S BATCH REVIEWS. AMSINO'S SPREADSHEET SHOWING WHERE THE COVIDIEN LOT WAS USED. PICKING /STAGING VERIFICATION FROM AMSINO'S LOT #'S KH03056 AND KH03050. CERTIFICATE OF COMPLIANCE FORM TYCO/KENDALL/COVIDIEN FOR THEIR LOT # 90610028.

    Description of Event or Problem · 1

    THE LUER LOCK BROKE OFF IN THE END OF THE CATHETER. THE PT HAD TO HAVE THE CATHETER REPAIRED. PLEASE SEE THE IMAGING REPORT FROM (B)(6) DATED (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSINO MEDICAL USA PRE-FILLED FLUSH SYRINGE 0.9% SODIUM CHL FOZ AMSINO MEDICAL USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention