BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE

    MDR report key: 7934858 · Received October 4, 2018

    Report

    Report Number
    1911916-2018-00553
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 12, 2018
    Report Date
    November 8, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE PHOTOS WERE ATTACHED FOR EVALUATION. THERE IS A PIECE OF WHAT APPEARS TO BE BLACK, COMPACTED PLASTIC DUST ON THE NEEDLE THEREFORE FAILURE MODE IS VERIFIED. PARTS ARE AIR-VEYED FROM ONE OPERATION TO THE NEXT. PLASTIC DUST ACCUMULATES, AND COMPACTS TO FORM A ¿SKIN¿ IN THE AIR-VEY PIPES. THIS PIECE APPEARS TO HAVE BROKEN LOOSE FROM ONE OF THE AIR-VEY SYSTEMS.THE AIR-VEY SYSTEMS ARE CLEANED WEEKLY, AND AT PRODUCT CHANGEOVERS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. ASSEMBLY BATCH 8026972 HAD 117 VISUAL INSPECTIONS PERFORMED ON 5,850 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 17 TIMES DURING THE ASSEMBLY OF THIS BATCH. ASSEMBLY BATCH 8050721 HAD 155 VISUAL INSPECTIONS PERFORMED ON 7,900 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 22 TIMES DURING THE ASSEMBLY OF THIS BATCH. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. INVESTIGATION CONCLUSION: PARTS ARE AIR-VEYED FROM ONE OPERATION TO THE NEXT. PLASTIC DUST ACCUMULATES, AND COMPACTS TO FORM A ¿SKIN¿ IN THE AIR-VEY PIPES. THIS PIECE APPEARS TO HAVE BROKEN LOOSE FROM ONE OF THE AIR-VEY SYSTEMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS NOTICED ON THE BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE AND NEEDLE HUB. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER WAS NOTICED ON THE BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE AND NEEDLE HUB. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777807 BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8117512 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 Other