BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 9356164 · Received November 21, 2019

    Report

    Report Number
    1911916-2019-01233
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED. THE PHOTO SHOWS A SYRINGE WITH BLACKENED BARREL. THE BARREL LABEL CONFIRMS THE LOT# 9231020. WHEN THE MOLDING PRESS HAS BEEN STOPPED AND RE STARTED AGAIN, THE FIRST MOLDING CYCLES MAY HAVE BLACKED BARRELS OR BURNT PLASTIC EMBEDDED IN THE BARREL WALLS. THE FIRST MOLDING CYCLES AFTER A RE START HAVE TO BE DISPOSED BEFORE THEY ARE SUPPLIED TO THE ASSEMBLY PROCESS. THIS IS AN ESCAPE FROM THOSE FIRST MOLDING CYCLES. THERE WAS DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE PRODUCTION RUN OF THIS BATCH. IT WAS DOCUMENTED THAT THE PLUNGER ROD OPERATOR FOUND BURNT BARRELS DURING A RANDOM OBSERVATION. QUALITY CONTROL WAS NOTIFIED AND, THEY CLEARED OUT THE LINE AND PERFORMED A QUALITY CHECK ON THE PALLET BACK TO THE LAST GOOD CHECK. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML REG PR SALINE 10ML FILL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546; BATCH NO.: 9231020 INK ON INSIDE OR OUTSIDE OF BARREL APPEARS TO HAVE RUN. SALINE INSIDE SYRINGE NOT COMPROMISED. SALINE STILL CLEAR. NOT USED ON PATIENT. ONLY 1 SYRINGE IN QUESTION.

    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 AN UNSPECIFIED NUMBER OF SYRINGE 10ML REG PR SALINE 10ML FILL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546 BATCH NO.: 9231020. INK ON INSIDE OR OUTSIDE OF BARREL APPEARS TO HAVE RUN. SALINE INSIDE SYRINGE NOT COMPROMISED. SALINE STILL CLEAR. NOT USED ON PATIENT. ONLY 1 SYRINGE IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153983 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9231020 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other