BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11715807 · Received April 23, 2021

    Report

    Report Number
    1911916-2021-00368
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    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

    CORRECTION B5. IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305125 BATCH NO.: 0022982. NEEDLES SEEM TO BE CONTAMINATED. A BLACK RING IS VISIBLE THIS LOT HAS BEEN SET ASIDE AND A FEW SAMPLES ARE AVAILABLE FOR RETURN. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-22. H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT THERE IS A BLACK RING AROUND THE NEEDLES. TO AID IN THE INVESTIGATION, FOUR SAMPLES AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THREE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND ONE SAMPLE CAME WITH NO PACKAGING BLISTER, IN A SMALL PLASTIC BAG AND WITH THE PLASTIC SHIELD. A VISUAL INSPECTION WAS PERFORMED UNDER A 30X MICROSCOPE. THERE IS A MARK IN THE NEEDLE ABOUT 1/4" FROM THE NEEDLE HUB. WE ATTEMPTED TO REMOVE THE MARK WITH AN ALCOHOL WIPE AND IT WAS NOT POSSIBLE. THE NEEDLE IS NOT DIRTY, IT IS THE METAL WITH A MARK ON IT. THE MARK IS NORMAL AND A PART OF THE NEEDLE MANUFACTURING PROCESS. THE THREE OTHER SAMPLES WERE INSPECTED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS ONE OF THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305125, LOT NUMBER 0022982. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE AND PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THE MARK SHOWN ON THE PHOTO AND THE SAMPLE ARE IMPERFECTIONS AND THEREFORE ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENT REPORTS FOR THE LOT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305125. BATCH NO.: 0022982. NEEDLES SEEM TO BE CONTAMINATED. A BLACK RING IS VISIBLE THIS LOT HAS BEEN SET ASIDE AND A FEW SAMPLES ARE AVAILABLE FOR RETURN.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305125, BATCH NO.: 0022982. NEEDLES SEEM TO BE CONTAMINATED. A BLACK RING IS VISIBLE (SEE ATTACHED PICTURE) THIS LOT HAS BEEN SET ASIDE AND A FEW SAMPLES ARE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615697 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0022982

    Patients

    Seq Age Sex Outcome Treatment
    1