BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10305864 · Received July 21, 2020

    Report

    Report Number
    1911916-2020-00661
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 24, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/14/2020. H.6. INVESTIGATION: NINETY-FIVE SAMPLES WERE RECEIVED IN ONE SHELF BOX FOR INVESTIGATION. THE SHELF BOX IS MARKED AS 305106 30 X ½¿. THE UNITS INSIDE THE SHELF BOX ARE IN PACKAGING BLISTERS WITH THE TOP WEB MARKED AS 305106 30X ½¿; HOWEVER, THE NEEDLE ASSEMBLIES INSIDE THE PACKAGING BLISTERS HAVE A 1¿ NEEDLE. TWO PHOTOS WERE PROVIDED. ONE PHOTO SHOWS FOUR SHELF BOXES. THE OTHER PHOTO SHOWS FOUR SHELF BOXES, THREE PACKAGING BLISTERS, AND ONE NEEDLE ASSEMBLY WITH NO PACKAGING OR PLASTIC SHIELD WITH A 1¿ NEEDLE. A POTENTIAL ROOT CAUSE FOR THE REPORTED CONDITION CAN BE ATTRIBUTED TO THE PACKAGING PROCESS, NEEDLES WITH 1¿ LENGTH WERE FED TO THE MACHINE AND NOT DETECTED DURING THE INSPECTIONS. BASED ON THE INVESTIGATION AND THE ANALYSIS OF THE SAMPLES AND PHOTOS PROVIDED, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THIS IS THE 1ST COMPLAINT TO THIS LOT#. WE WILL CONTINUE MONITORING THIS LOT AND PRODUCT FOR THIS SYMPTOM. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE WERE 1 INCH NEEDLES RATHER THAN THE 1/2 INCH THAT THEY WERE LABELED WITH. THIS OCCURRED ON 400 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106 BATCH NO: 9193522 IT WAS REPORTED THAT LABELS ON 4 PACKAGES HAVE 30GX 1/2 ON THEM, BUT THE NEEDLES APPEAR TO BE 1 INCH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BD PRECISIONGLIDE¿ NEEDLE WERE 1 INCH NEEDLES RATHER THAN THE 1/2 INCH THAT THEY WERE LABELED WITH. THIS OCCURRED ON 400 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106 BATCH NO: 9193522. IT WAS REPORTED THAT LABELS ON 4 PACKAGES HAVE 30GX 1/2 ON THEM, BUT THE NEEDLES APPEAR TO BE 1 INCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770320 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other