BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERFUSION¿ SYRINGE W/NEEDLE

    MDR report key: 7527797 · Received May 18, 2018

    Report

    Report Number
    3003152976-2018-00216
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 19, 2018
    Report Date
    May 16, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION: DEFECT: FOREIGN MATTER ¿ PP PARTICLES AND DIRT INSIDE THE SYRINGE. IT HAS BEEN RECEIVED (B)(4) USED SAMPLE OF 50PF LOT 1801216 FOR INVESTIGATION. UPON VISUAL INSPECTION OF THIS SAMPLE RECEIVED IT CAN BE OBSERVED A BROWN PARTICLE INSIDE THE SYRINGE. DHR OF LOT 1801216 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. ON INSPECTION AT 10X, IT CAN BE OBSERVED THIS BROWN PARTICLE IS FORMED BY POLYPROPYLENE FIBERS AND DIRT. THESE PARTICLES COME FROM MOLDING AND TRANSPORT PROCESSES. EQUIPMENT OF MANUFACTURING LINE IS REGULARLY CLEANED ACCORDING TO PROCEDURE JG-039: ONCE PER SHIFT OR DURING ANY LONG STOP OF THE MANUFACTURING LINE. ALWAYS ANY KIND OF CONTAMINATION OR POTENTIAL CONTAMINATION IS DETECTED IN AREAS IN CONTACT WITH THE PRODUCT. DURING MECHANICAL MAINTENANCE OF THE LINE. ALSO CRITICAL POINTS: DURING PROGRAMMED STOPS OF MOLDING MACHINES. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. VISUAL INSPECTION: MOLDING: 2 INJECTIONS PER SHIFT. PRINTING: 24 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 6 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. PRIMARY PACKAGING: 1 ADVANCE-STEP (WITHOUT PRODUCT) PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. SECONDARY PACKAGING: 1 SHELF-PACKAGE PER PALLET. FUNCTIONAL INSPECTION: PRINTING: ONCE IN THE FIRST PALLET, ONCE IN THE MIDDLE OF THE LOT AND ONCE IN LAST PALLET OF THE LOT. ASSEMBLY: ONCE IN THE FIRST PALLET, ONCE IN THE MIDDLE OF THE LOT AND ONCE IN LAST PALLET OF THE LOT. PRIMARY PACKAGING: ONCE IN THE FIRST PALLET, ONCE IN THE MIDDLE OF THE LOT AND ONCE IN LAST PALLET OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PERFUSION¿ SYRINGE W/NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿AFTER DRAWING OF NACL INTO THE PERFUSION SYRINGE, THE CUSTOMER NOTICED THAT A (FRUIT) FLY HAS COME OFF THE PLUNGER. IT STILL ADHERES TO THE HEAD OF THE SYRINGE". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368161 BD PERFUSION¿ SYRINGE W/NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. 1801216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other