BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

    MDR report key: 8204121 · Received December 28, 2018

    Report

    Report Number
    3003152976-2018-00567
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 12, 2018
    Report Date
    March 6, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN SECTION H.10 OF THE PREVIOUSLY SUBMITTED MDR, SECTIONS D.1 AND H.1 WERE INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THOSE REFERENCES TO SHOW THE FOLLOWING: D.4 MEDICAL DEVICE EXPIRATION DATE. H.4 DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: QUANTITY OF CUSTOMER SAMPLES: 1 SEALED SAMPLE OF 10LL LOT 1803011 AND 2 PICTURES (1 OF A 30LL SYRINGE AND 1 OF A 10LL SYRINGE). DATE CUSTOMER SAMPLES RECEIVED: 09/DEC/2018. IT HAS BEEN RECEIVED 1 SEALED SAMPLE OF 10LL LOT 1803011 AND 2 PICTURES (1 OF A 30LL SYRINGE AND 1 OF A 10LL SYRINGE) FOR INVESTIGATION. UPON VISUAL INSPECTION OF THIS SAMPLE AND PICTURE OF 10LL SYRINGE IT CAN BE OBSERVED THAT THE SCALE IS PARTIALLY ERASED IN LINE 0 OF THE SCALE. IT CAN ALSO BE OBSERVED A FIBER INSIDE THE SYRINGE ON THE STOPPER. UPON VISUAL INSPECTION OF THIS SAMPLE AT 10X IT CAN BE CONFIRMED THIS FIBER IS POLYPROPYLENE FIBER. THIS PARTICLE COMES FROM MOLDING AND TRANSPORT PROCESSES OF SYRINGES. THE SIZE OF THIS PARTICLE IS 2,5 MM. ACCORDING TO INSPECTION PLAN PROCEDURE, PP PARTICLES >0.8MM INSIDE FLUID PAD HAVE AN AQL OF 1% (IT MEANS AN ACCEPTANCE CRITERIA OF 5 DEFECTIVE SAMPLES ALLOWED ¿ MORE THAN 5 NOT ALLOWED PER LOT). SINCE THE OCCURRENCE IS 1 SAMPLE, IT MEETS ACCEPTANCE CRITERIA. DHR OF LOT 1803011 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION REGARDING THE ALLEGED DEFECT. 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: 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. WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH TRANSPORTS IN MANUFACTURING AREA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ HAD FOREIGN MATTER AND SCALE MARKING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ HAD FOREIGN MATTER AND SCALE MARKING ISSUE.

    Additional Manufacturer Narrative · 1

    (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 BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ HAD FOREIGN MATTER AND SCALE MARKING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044224 BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other