BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL

    MDR report key: 11349256 · Received February 19, 2021

    Report

    Report Number
    1213809-2021-00092
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF THE TOP VIEW OF A BLISTER PACK FROM BATCH 0061732 (P/N 309628) WAS RECEIVED AND EVALUATED. NO DEFECTS COULD BE CONFIRMED BASED ON THE PHOTO. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML LL SCALE MARKINGS WERE ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628 BATCH NO: 0061732. IT WAS REPORTED THAT AS THE WRITER WAS PEELING BACK THE PACKAGING FOR A 1ML LUER LOCK, ALL OF THE NUMBERS AND LINES WERE COMPLETELY SMUDGED, AND WERE NOT LEGIBLE. VERBATIM: AS THE WRITER WAS PEELING BACK THE PACKAGING FOR A 1ML LUER LOCK, ALL OF THE NUMBERS AND LINES WERE COMPLETELY SMUDGED, AND WERE NOT LEGIBLE. WRITER PRESENTED THE SYRINGE TO ANOTHER NURSE ON THE FLOOR, AND ENSURED THERE WERE NO MORE IN THE BOX OF 1ML SYRINGES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML LL SCALE MARKINGS WERE ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628 BATCH NO: 0061732 IT WAS REPORTED THAT AS THE WRITER WAS PEELING BACK THE PACKAGING FOR A 1ML LUER LOCK, ALL OF THE NUMBERS AND LINES WERE COMPLETELY SMUDGED, AND WERE NOT LEGIBLE. VERBATIM: AS THE WRITER WAS PEELING BACK THE PACKAGING FOR A 1ML LUER LOCK, ALL OF THE NUMBERS AND LINES WERE COMPLETELY SMUDGED, AND WERE NOT LEGIBLE. WRITER PRESENTED THE SYRINGE TO ANOTHER NURSE ON THE FLOOR, AND ENSURED THERE WERE NO MORE IN THE BOX OF 1ML SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248715 SYRINGE 1ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0061732 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1