BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10135662 · Received June 9, 2020

    Report

    Report Number
    1911916-2020-00542
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED FOR EVALUATION. THE PHOTOS SHOW A TOP WEB PACKAGING BLISTER WITH A NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD ON THE SIDE. THE NEEDLE HAS WHITE EPOXY ON THE NEEDLE. ADDITIONALLY, TWO SAMPLES WERE RECEIVED FOR INVESTIGATION. ONE SAMPLE HAS NO PACKAGING BLISTER AND IT HAS THE PLASTIC SHIELD. IT HAS THE EPOXY ON THE NEEDLE. THIS IS THE SAMPLE SHOWN IN THE PHOTOS. THE OTHER SAMPLE IS IN A SEALED PACKAGING BLISTER. IT HAS A HANDWRITTEN NOTE ¿TO CHECK THE LOT#¿. THE LOT # IS THE SAME REPORTED AS 9162864. THIS IS THE 1ST COMPLAINT FOR THIS LOT AND PRODUCT. THIS LOT WAS PRODUCED FOR 1.4MM UNITS. THIS GIVES A CPM OF 0.7. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9162864 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THE POTENTIAL ROOT CAUSE CAN BE ATTRIBUTED TO THE NEEDLE ASSEMBLY LINE. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. AFTER THAT, A PLASTIC HUB IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE EXCESS OF WHITE EPOXY ON THE NEEDLE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND ON THE BD PRECISIONGLIDE¿ NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATTER ON THE NEEDLE - SOMETHING WHITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600343 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9162864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other