BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE

    MDR report key: 9722878 · Received February 18, 2020

    Report

    Report Number
    3003152976-2020-00067
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 28, 2020
    Report Date
    April 6, 2020
    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
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED . THE PRODUCT WAS VISUALLY INSPECTED AND DAMAGE WAS FOUND ON THE SYRINGE BARREL. IT WAS NOTED THE STOPPER BECAME DISTORTED AGAINST THE BARREL WALL WHEN MOVING ACROSS THE DAMAGED PORTION, RESULTING IN THE LEAK THAT WAS REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1909003, 1910005, 1910007, 1910002, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. DHR OF LOT 1909003 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DHR OF LOT 1910005 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DHR OF LOT 1910007 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DHR OF LOT 1910002 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. 1. VISUAL INSPECTION MOLDING: 2 INJECTIONS PER SHIFT. PRINTING: 24 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 24 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. ALTHOUGH NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, WE CAN CONFIRM THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED TO BARREL JAMMED IN TRANSFERENCE WHEELS OF ASSEMBLY MACHINE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THE EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. ADDITIONAL INFORMATION FOR SUSPECTED LOTS: LOT # 1909003. G.4 CREATED ON 09/03/2019. D.4 EXPIRATION DATE 08/31/2024. LOT # 1910005, G.4 CREATED ON 10/14/2019, D.4 EXPIRATION DATE 09/30/2024. LOT # 1910007, G.4 CREATED ON 10/17/2019, D.4 EXPIRATION DATE 09/30/2024. LOT # 1910002, G.4 CREATED ON 10/04/2019, D.4 EXPIRATION DATE 09/30/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE LEAKED DURING USE WHILE DRAWING UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF OUR STAFF NURSES IN SFL LEFT A SYRINGE FOR ME IN MY OFFICE AS IT WAS LEAKING WHEN DRAWING UP MEDICATION, AS THOUGH THERE WASN¿T A GOOD SEAL BETWEEN THE BARREL AND THE PLUNGER. IT¿S A 10ML BD PLASTIPAK LEURLOK IV SYRINGE. I DON¿T HAVE THE PACKAGING AS IT HAD BEEN THROWN OUT BEFORE THE GIRLS REALISED THE SYRINGE WAS FAULTY."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE LEAKED DURING USE WHILE DRAWING UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF OUR STAFF NURSES IN SFL LEFT A SYRINGE FOR ME IN MY OFFICE AS IT WAS LEAKING WHEN DRAWING UP MEDICATION, AS THOUGH THERE WASN¿T A GOOD SEAL BETWEEN THE BARREL AND THE PLUNGER. IT¿S A 10 ML BD PLASTIPAK LEURLOK IV SYRINGE. I DON¿T HAVE THE PACKAGING AS IT HAD BEEN THROWN OUT BEFORE THE GIRLS REALISED THE SYRINGE WAS FAULTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187463 BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other