BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 8387137 · Received March 4, 2019

    Report

    Report Number
    9610847-2019-00191
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 12, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE VISUAL AID PG-119-WI-001SP HAS BEEN SHARED WITH THE EMPLOYEES TO TRAIN ALL PERSONNEL IN THE CORRECT HANDLING OF BAGS DURING THE PROCESS TO PREVENT CARDBOARD PARTICLES FALLING INSIDE TRAYS. THIS TRAINING WAS PROVIDED TO ASSOCIATES ON THE CORRECT PRACTICE FOR LOADING THE SYRINGES INTO FEEDER BOWLS. CORRECT PRACTICE IS TO LIFT WITH ONLY THE INNER POLYBAG (LEAVING OUTER POLYBAG WITHIN THE CASE) TO POUR/DROP THE SYRINGES IN THE FEEDER BOWL. THIS PREVENTS THE UNWANTED RESIDUES FROM CASES FROM ENTERING THE TRAYS/PRODUCTS. NOTIFY INCOMING INSPECTION ABOUT THE BLACK SPEC IN SYRINGE PLUNGER. COMPLAINT HISTORY CHECK FOR LOT 8246681 WAS VERIFIED AND NO DISCREPANCIES WERE FOUND ABOUT THE ABOVE DESCRIBED PROBLEMS. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITIONS ON LOT NUMBER 8246681. NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 8246681 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 8246681, CATALOGUE #: 309680 QUANTITY PRODUCED: 43,220 PCS. 60ML TRAY LOT (P/N 500014782) USED IS 2018356 FOR LOT 8246681. 60ML SYRINGE LOT (P/N 8000952) USED ARE 8054983 & 8054986 FOR LOT 8246681. NO QN¿S WERE FOUND FOR LOTS 8246681, 8054983, 8054986 & 2018356 IN SAP AND INCOMING INSPECTION RECORDS. DURING THE MANUFACTURE OF THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED BEFORE PACKAGING THE PRODUCT IN DISPENSERS LOOKING FOR FOREIGN MATERIAL INSIDE THE TRAY AND SYRINGES. DURING THE 100% INSPECTION NO PARTS WITH FOREIGN MATERIAL WERE FOUND BY OUR OPERATORS. BASED ON THE SAMPLES AND PICTURES RECEIVED, ASSEMBLED SYRINGES COMING FROM COLUMBUS, COMES PACKAGED IN DOUBLE POLYBAGS PLACED INTO CASE CARTON. IT WAS IDENTIFIED AT NOGALES, BOTH POLYBAGS WERE BEING LIFTED TO POUR/LOAD ASSEMBLED SYRINGES INTO THE FEEDER BOWLS. CARDBOARD PIECES FROM CASE BOXES STUCK TO THE OUTER POLYBAG ALSO DROPPED INTO THE FEEDER BOWL THAT LATER FOUND THEIR WAY INTO THE TRAYS. THE BLACK SPEC IN THE SYRINGE PLUNGER IS LIKELY COMING FROM THE COLUMBUS MOLDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY FOREIGN PARTICULATE WAS FOUND IN THE TRAY AND ONE SYRINGE IN THE TRAY WAS FOUND WITH A BLACK SPEC ON THE PLUNGER ROD UNDER THE STOPPER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY FOREIGN PARTICULATE WAS FOUND IN THE TRAY AND ONE SYRINGE IN THE TRAY WAS FOUND WITH A BLACK SPEC ON THE PLUNGER ROD UNDER THE STOPPER. EVENT DESCRIPTION PER CUSTOMER'S EMAIL STATES, "ONE (1) SYRINGE TRAY WITH PARTICULATE MATTER INSIDE THE TRAY. ALSO, WITHIN THIS TRAY WAS FOUND A SINGLE UNUSED SYRINGE WITH A BLACK SPECK OF MATERIAL ON THE PLUNGER ROD JUST UNDER THE BLACK RUBBER SEAL (THE PLUNGER ROD WAS NOT EXPELLED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178782 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8246681 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other