BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE WITH NEEDLE

    MDR report key: 7060590 · Received November 27, 2017

    Report

    Report Number
    3002682307-2017-00097
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 10, 2017
    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
    CH
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION. WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE WHICH SHOW SPRINKLED EPOXY (ADHESIVE USED TO JOIN METAL PART AND HUB PLASTIC PART, NOT CONTAMINATION) ON THE EXTERNAL HUB WALL. BHR REVIEW. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2020 (SEPTEMBER 2 - 3RD, 2016). NEEDLES WERE ASSEMBLED IN LOT #6214070. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE EPOXY LOT #I661902218, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE HUB LOT #6230035, AND #6196245 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE CANNULA LOT #6099313, AND #6062162 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE DESCRIPTION: ROOT CAUSE ANALYSIS. THIS ISSUE OCCURRED IN THE ASSEMBLY PROCESS IN WHICH THE ADHESIVE IS ADDED TO THE HUB, PROBABLY BECAUSE OF SOME BLOCKAGE OR JUMP, EXCESSIVE QUANTITY OF EPOXY WAS DOSAGE RESULTING IN THE REPORTED ISSUE. FINALLY, EPOXY WAS CURED ON HUB WALL. DURING IN-PROCESS QUALITY INSPECTION, OPERATOR DETECTED THE ISSUE, HOWEVER, AFFECTED MATERIALS WERE NOT APPROPRIATELY SEGREGATED PROBABLY DUE TO A HUMAN ERROR. BASED ON OUR EXPERIENCE, THE PROBABILITY OF OCCURRENCE OF THIS NON-CONFORMANCE SHOULD BE VERY LOW SUPPORTED BY THE LOW PERCENTAGE OF DEFECTS IDENTIFIED IN OUR ROUTINE IN-PROCESS INSPECTIONS. CONFIRMATION: THE PROVIDED PICTURE AND SAMPLE CONFIRMED THAT THE FOREIGN MATTER IN THE HUB OF THE NEEDLE, WAS COMPOSED BY ADHESIVE. CAPA DETERMINATION: NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 5ML SYRINGE WITH NEEDLE HAD WHITE FOREIGN MATTER AT THE TIP OF THE CATHETER. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841246 BD 5ML SYRINGE WITH NEEDLE SYRINGE W/ NEEDLE FMF BECTON DICKINSON, S.A. 1609121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other