BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 10502655 · Received September 8, 2020

    Report

    Report Number
    1213809-2020-00605
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON:(B)(6) 2020. H.6. INVESTIGATION: ONE 10ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 9233256 WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS SOME BROWN PARTICULATE OUTSIDE THE FLUID PATH, ATTACHED TO THE BOTTOM OF THE PLUNGER ROD. THE PARTICULATE APPEARED TO BE OIL AND WAS LARGE ENOUGH IN SIZE TO BE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROWN DIRT INSIDE THE SYRINGE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROWN DIRT INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970109 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 300912 9233256 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other