BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8340028 · Received February 14, 2019

    Report

    Report Number
    3003152976-2019-00150
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 24, 2019
    Report Date
    March 12, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    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 SUMMARY: IT HAS BEEN RECEIVED 3 SEALED SAMPLES OF 50LL LOT 1811230, 4 SEALED SAMPLES OF 50LL LOT 1811259 AND 3 SEALED SAMPLES OF 50LL LOT 1810221 FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED OF LOT 1811230, SMALL PARTICLES CAN BE OBSERVED INSIDE THE BLISTER, OUTSIDE THE SYRINGES. NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN ANY OF THE 3 SAMPLES. UPON INSPECTION AT 10X OF THE FIRST SAMPLE, IT CAN BE OBSERVED TWO POLYPROPYLENE PARTICLES OUTSIDE THE SYRINGE. THE SIZE OF THESE PARTICLES ARE 0,087MM AND 0,11 MM. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE FLUID PATH. UPON INSPECTION AT 10X OF THE SECOND SAMPLE, IT CAN BE OBSERVED ONE POLYPROPYLENE PARTICLE OUTSIDE THE SYRINGE. THE SIZE OF THIS PARTICLE IS 0,12 MM. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE FLUID PATH. UPON VISUAL INSPECTION OF THE THIRD SAMPLE IT CAN BE OBSERVED A PAPER PARTICLE OUTSIDE THE SYRINGE. THE SIZE OF THIS PARTICLE IS 0,37 MM. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE FLUID PATH. UPON VISUAL INSPECTION OF THE 3 SAMPLES RECEIVED OF LOT 1810221, NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE BLISTERS. BUT BLACK FOREIGN MATTER CAN BE OBSERVED ON THE PLUNGER NERVE OF ONE OF THE SAMPLES. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE OTHER TWO SYRINGES. UPON INSPECTION AT 10X IT CAN BE CONFIRMED THIS BLACK FOREIGN MATTER IS EMBEDDED MATERIAL FROM MOLDING PROCESS. NO DAMAGE IS OBSERVED IN ANY OF THE THREE SAMPLES. UPON VISUAL INSPECTION OF 4 SAMPLES RECEIVED OF LOT 1811259, SMALL PARTICLES CAN BE OBSERVED INSIDE THE BLISTER, OUTSIDE THE SYRINGES. UPON INSPECTION AT 10X OF THE FIRST SAMPLE, IT CAN BE OBSERVED ONE POLYPROPYLENE PARTICLE OUTSIDE THE SYRINGE. THE SIZE OF THIS PARTICLE IS 0,47MM. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE FLUID PATH. UPON INSPECTION AT 10X OF THE SECOND SAMPLE, IT CAN BE OBSERVED TWO POLYPROPYLENE PARTICLES OUTSIDE THE SYRINGE. THE SIZE OF THESE PARTICLES ARE 0,46 MM AND 0,48 MM. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE FLUID PATH. UPON VISUAL INSPECTION OF THE THIRD SAMPLE IT CAN BE OBSERVED A POLYPROPYLENE PARTICLE OUTSIDE THE SYRINGE. THE SIZE OF THIS PARTICLE IS 1,35 MM. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE FLUID PATH. UPON VISUAL INSPECTION OF THE FOURTH SAMPLE IT CAN BE OBSERVED A POLYPROPYLENE PARTICLE OUTSIDE THE SYRINGE. THE SIZE OF THIS PARTICLE IS 1,27 MM. NO FOREIGN MATTER CAN BE OBSERVED INSIDE THE FLUID PATH. POLYPROPYLENE PARTICLES COME FROM MOLDING AND TRANSPORT PROCESSES. PAPER PARTICLE CAN COMES FROM THE PAPER OF THE BLISTER. THESE FOREIGN MATTER ARE WITHIN SPECIFICATION LIMITS AND ACCEPTANCE CRITERIA. DHR OF LOT 1804240 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING LEAKAGE DEFECT. DHR OF LOT 1811230 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING FOREIGN MATTER DEFECT. DHR OF LOT 1810221 AND 1811259 HAS BEEN REVIEWED FINDING AN ANNOTATION RELATED TO PARTICLES FOUND DURING MANUFACTURING PROCESS. 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. IN ASSEMBLY STATION OF THIS MANUFACTURING LINE, THERE IS A DE-IONIZER TO REMOVE POLYPROPYLENE 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. ON FEBRUARY 2019 A VACUUM SYSTEM HAS ALSO BEEN INSTALLED IN PACKAGING MACHINE OF THIS MANUFACTURING LINE TO REDUCE FOREIGN MATTER INSIDE THE BLISTERS. (THIS LOT WAS MANUFACTURED IN NOVEMBER 2018) 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. ROOT CAUSE: PARTICLES DEFECT: MOLDING AND TRANSPORT PROCESSES. EMBEDDED MATERIAL: MOLDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HAD LEAKAGE PAST THE STOPPER WITH WITH LOT# 1804240, THIS OCCURRED ONCE. IT WAS ALSO REPORTED THAT MANY DEVICES HAD FOREIGN MATTER IN THE FORM OF LOOSE PARTICLES IN THE PACKAGING WITH LOT NUMBERS 1811230, 1811259, AND 1810221. THE OCCURRENCES ASSOCIATED WITH EACH LOT ARE 63, 34, AND 34 RESPECTIVELY. THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN FOR EACH OCCURRENCE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1804240, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-04-24. MEDICAL DEVICE LOT #: 1811230, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2018-11-13. MEDICAL DEVICE LOT #: 1811259, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2018-11-29. MEDICAL DEVICE LOT #: 1810221, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2018-10-05. 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 A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HAD LEAKAGE PAST THE STOPPER WITH LOT# 1804240, THIS OCCURRED ONCE. IT WAS ALSO REPORTED THAT MANY DEVICES HAD FOREIGN MATTER IN THE FORM OF LOOSE PARTICLES IN THE PACKAGING WITH LOT NUMBERS 1811230, 1811259, AND 1810221. THE OCCURRENCES ASSOCIATED WITH EACH LOT ARE 63, 34, AND 34 RESPECTIVELY. THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN FOR EACH OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131321 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other