BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8280472 · Received January 27, 2019

    Report

    Report Number
    3003152976-2019-00109
    Event Type
    Malfunction
    Date Received
    January 27, 2019
    Date of Event
    January 9, 2019
    Report Date
    April 5, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS AND ONE PHYSICAL SAMPLE WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTOS AND PRODUCT RETURNED, A PARTICLE WAS OBSERVED INSIDE THE SYRINGE. USING MAGNIFICATION, THE PARTICLES WERE IDENTIFIED AS POLYPROPYLENE FIBERS FROM THE BARRELS LUBRICATION PROCESS IN THE ASSEMBLY MACHINE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1810261, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. IT WAS DETERMINED THIS ISSUE OCCURRED AS A RESULT OF IMPROPER CLEANING OF THE MACHINE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT HAS BEEN RECEIVED 2 PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PICTURES RECEIVED, IT CAN BE OBSERVED A PARTICLE INSIDE THE SYRINGE. DUE TO PICTURE RESOLUTION, THE COMPOSITION AND ORIGIN OF THE PARTICLE CANNOT BE DETERMINED SO THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. DHR OF LOT 1810261 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. MANUFACTURING AREA FOR 50LL SYRINGES IS A STANDARD CLEAN AREA ISO9 WHICH IS UNDER A POSITIVE PRESSURE TO PUSH DUST AND PARTICLES OUT OF THE MANUFACTURING AREA. 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: 32 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 32 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. 2.FUNCTIONAL INSPECTION: PRINTING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. ASSEMBLY: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. PRIMARY PACKAGING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. IN ASSEMBLY STATION OF THIS MANUFACTURING LINE, THERE IS A DE-IONIZER TO REMOVE PARTICLES INSIDE THE BARREL. IN ADDITION, 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. SINCE NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, AND THE COMPOSITION OF THE PARTICLE CANNOT BE APPRECIATED ON PICTURES RECEIVED, THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73082 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1810261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other