BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL NS

    MDR report key: 8374616 · Received February 27, 2019

    Report

    Report Number
    3003152976-2019-00183
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT HAS BEEN RECEIVED 1 UNUSED SAMPLE OF 20ML LL AND 2 PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE AND PICTURES RECEIVED, IT CAN BE OBSERVED A HAIR INSIDE THE SYRINGE BARREL BEHIND THE STOPPER. DHR OF LOT 1801352 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. MANUFACTURING AREA FOR 20ML SYRINGES IS A STANDARD CLEAN AREA ISO8 WHICH IS UNDER A POSITIVE PRESSURE TO PUSH DUST AND PARTICLES OUT OF THE MANUFACTURING AREA. OPERATORS WEAR PROTECTIVE CLOTHES (HAIR-COVES, MOUSTACHE-COVER, COAT, BEARD-COVER, SHOES-COVER) ACCORDING TO INTERNAL PROCEDURE (HA-012). THIS DEFECT HAS BEEN CAUSED BECAUSE OPERATOR DOES NOT FOLLOW THE CLOTHING RULES ACCORDING TO PROCEDURE HA-012. 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: 18 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 18 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. PACKAGING: 1 ADVANCE-STEP (WITHOUT PRODUCT) PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. 2. FUNCTIONAL INSPECTION PRINTING: ONCE IN THE FIRST PALLET, ONCE IN LAST PALLET OF THE LOT PLUS ONCE PER DAY. ASSEMBLY: ONCE IN THE FIRST PALLET, ONCE IN LAST PALLET OF THE LOT PLUS ONCE PER DAY. ALTHOUGH NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH HUMAN ERROR. THE ROOT CAUSE IS THAT OPERATOR DOES NOT FOLLOW THE CLOTHING RULES ACCORDING TO PROCEDURE. QUALITY PROJECT#1442 IS OPEN TO REDUCE THIS FOREIGN MATTER IN THIS PRODUCT. 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 THE SYRINGE 20ML LL NS EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (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 THE SYRINGE 20ML LL NS EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166023 SYRINGE 20ML LL NS SYRINGE FMF BECTON DICKINSON, S.A. 1801352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other