BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOCK SYRINGE

    MDR report key: 8001840 · Received October 24, 2018

    Report

    Report Number
    3003152976-2018-00444
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    September 24, 2018
    Report Date
    November 8, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR OF LOT 1803212 HAS BEEN REVIEWED FINDING AN ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING ASSEMBLY PROCESS STOPPER WRONG ASSEMBLED WERE DETECTED DUE TO A MISALIGNMENT OF STOPPER AND PLUNGER IN ASSEMBLY STATION. PRODUCT INSPECTION WAS DONE REJECTING TO SCRAP DEFECTIVE SAMPLES DETECTED AND MECHANICAL TEAM REPAIRED THE FAILURE. ONE PHYSICAL SAMPLE UNIT AND ONE PICTURE SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE SAMPLE, THE STOPPER WAS OBSERVED PARTIALLY DISASSEMBLED FROM THE PLUNGER. THE SAMPLE WAS DISASSEMBLED AND NO DAMAGES OR MOLDING DEFECTS WERE OBSERVED TO THE PLUNGER ROD THAT COULD HAVE CAUSED THE STOPPER SEPARATION. 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 BD PLASTIPAK¿ LUER-LOCK SYRINGE HAD PLUNGER SEPARATION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ LUER-LOCK SYRINGE HAD PLUNGER SEPARATION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843529 BD PLASTIPAK¿ LUER-LOCK SYRINGE CONVENTIONAL SYRINGE FMF BECTON DICKINSON, S.A. 1803212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other