BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOCK SYRINGE

    MDR report key: 8241075 · Received January 11, 2019

    Report

    Report Number
    3003152976-2018-00585
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 20, 2018
    Report Date
    February 6, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT HAS BEEN RECEIVED 1 UNUSED SAMPLE OF 30LL LOT 1810216 WITH OPEN BLISTER FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE RECEIVED, IT CAN BE OBSERVED THE STOPPER IS DISASSEMBLED FROM THE PLUNGER. NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN THE PLUNGER ROD THAT COULD HAVE CAUSED THIS DEFECT. DHR OF LOT 1810216 HAS BEEN REVIEWED FINDING AN ANNOTATION REGARDING THE ALLEGED DEFECT. DURING ASSEMBLY PROCESS A FAILURE WAS DETECTED IN ASSEMBLY STATION THAT CAUSED THE STOPPERS WERE NOT CORRECTLY ASSEMBLED TO PLUNGERS. ONCE DETECTED, DEFECTIVE SAMPLES DETECTED WERE REJECTED AND MECHANICAL TEAM REPAIRED THE FAILURE. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES (JG-301, JG-302, JG-303 AND JG-304): 1.VISUAL INSPECTION MOLDING: 2 INJECTIONS PER SHIFT PRINTING: 10 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 10 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 TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. SECONDARY PACKAGING: 1 SHELF PACKAGE PER PALLET. 2.FUNCTIONAL INSPECTION PRINTING: ONCE IN PALLET#1, ONCE IN PALLET#7, ONCE IN PALLET#14 AND ONCE IN PALLET#22. ASSEMBLY: ONCE IN PALLET#1, ONCE IN PALLET#7, ONCE IN PALLET#14 AND ONCE IN PALLET#22. PRIMARY PACKAGING: ONCE IN PALLET#1, ONCE IN PALLET#7, ONCE IN PALLET#14 AND ONCE IN PALLET#22. WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH THE FAILURE DETECTED DURING MANUFACTURING PROCESS IN THE ASSEMBLY STATION. PROJECT#1688 HAS BEEN OPENED TO INSTALL A VISION SYSTEM IN THE ASSEMBLY STATION TO DEFECT THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ LUER-LOCK SYRINGE THE SILICON STOPPER CAME OFF THE PLUNGER INSIDE THE SYRINGE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 DURING USE OF THE BD PLASTIPAK¿ LUER-LOCK SYRINGE THE SILICON STOPPER CAME OFF THE PLUNGER INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31451 BD PLASTIPAK¿ LUER-LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1810216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other