BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 7531654 · Received May 22, 2018

    Report

    Report Number
    3003152976-2018-00215
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 7, 2018
    Report Date
    June 7, 2018
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE UNUSED SAMPLE HAS BEEN RECEIVED OF 50LL LOT 1802221 FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE RECEIVED, WHITE FOREIGN MATTER CAN BE OBSERVED ON THE STOPPER. THIS WHITE FOREIGN MATTER IS SILICONE FROM STOPPERS. STOPPER ARE LUBRICATED (WITH MEDICAL GRADE SILICONE) AND SUPPLIED BY EXTERNAL SUPPLIER. DURING ASSEMBLY PROCESS STOPPERS ARE LOCATED IN STOPPER-FEEDERS TO BE ASSEMBLED TO PLUNGERS IN ASSEMBLY WHEEL. LUBRICATION FROM STOPPERS REMAINED ACCUMULATED IN THIS STOPPER-FEEDER CAUSING IT RESULTED ATTACHED TO THE STOPPER. DHR OF LOT 1802221 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. EQUIPMENT OF MANUFACTURING LINE IS REGULARLY CLEANED ACCORDING TO PROCEDURE. 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: 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 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 THE FIRST PALLET AND ONCE IN THE LAST PALLET OF THE LOT. -ASSEMBLY: ONCE IN THE FIRST PALLET AND ONCE IN THE LAST PALLET OF THE LOT. -PRIMARY PACKAGING: ONCE IN THE FIRST PALLET AND ONCE IN THE LAST PALLET OF THE LOT. INVESTIGATION CONCLUSION: DURING ASSEMBLY PROCESS STOPPERS ARE LOCATED IN STOPPER-FEEDERS TO BE ASSEMBLED TO PLUNGERS IN ASSEMBLY WHEEL. LUBRICATION FROM STOPPERS REMAINED ACCUMULATED IN THIS STOPPER-FEEDER RESULTING IN IT BEING ATTACHED TO THE STOPPER.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE A BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS FOUND WITH FOREIGN MATTER AS ¿DIRT IN SYRINGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378282 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON, S.A. 1802221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other