BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 9648262 · Received January 30, 2020

    Report

    Report Number
    1911916-2020-00072
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 21, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A DEFAULT. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9226357. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2019-08-14. MEDICAL DEVICE LOT #: 9057787. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-02-26. MEDICAL DEVICE LOT #: 8250581. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2018-09-07. MEDICAL DEVICE LOT #: 8228917. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2018-08-16. MEDICAL DEVICE LOT #: 9193523. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-07-12. MEDICAL DEVICE LOT #: 9162858. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-06-11. MEDICAL DEVICE LOT #: 9093838. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-04-03. MEDICAL DEVICE LOT #: 5274755. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2015-10-01. MEDICAL DEVICE LOT #: 6006572. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2016-01-06. MEDICAL DEVICE LOT #: 6152917. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30. DEVICE MANUFACTURE DATE: 2016-05-31. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: 3900 SAMPLES WERE RECEIVED IN SHELF BOXES. THEY ARE IN SEALED PACKAGING BLISTER. ADDITIONALLY, TWO PLASTIC BAGS WERE RECEIVED WITH NEEDLE ASSEMBLIES IN THEIR SEALED PACKAGING BLISTER. ANOTHER PLASTIC BAG WAS RECEIVED WITH NEEDLE ASSEMBLIES AND NO PACKAGING BLISTER. THESE HAVE THE PLASTIC SHIELD. FINALLY, ONE PLASTIC BAG WITH ONE SYRINGE (2 ½ ML) WITH A LABEL INDICATING IT CONTAINS LIDOCAINE AND EPINEPHRINE. IT IS CONNECTED TO A NEEDLE ASSEMBLY WITH ITS PLASTIC SHIELD. IN THE SAME BAG THERE ARE ANOTHER FOUR NEEDLE ASSEMBLIES WITH PLASTIC SHIELDS. THESE FOUR NEEDLE ASSEMBLIES AND THE ONE CONNECTED TO THE SYRINGE SHOW THE NEEDLE WITH RUST. FAILURE MODE FOR THESE NEEDLES WAS VERIFIED HOWEVER, ROOT CAUSE IS UNDETERMINED. IT IS UNCLEAR TO WHAT KIND OF SOLUTION THE ONES WITH RUST WERE EXPOSED AND FOR HOW LONG. 1000 SAMPLES WERE VISUALLY INSPECTED UNDER THE MICROSCOPE 30X FINDING THEM ALL GOOD. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLES PROVIDED. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH #S. ROOT CAUSE DESCRIPTION: FAILURE MODE FOR THESE NEEDLES WAS VERIFIED HOWEVER, ROOT CAUSE IS UNDETERMINED. IT IS UNCLEAR TO WHAT KIND OF SOLUTION THE ONES WITH RUST WERE EXPOSED AND FOR HOW LONG. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RUST WAS FOUND ON THE BD PRECISIONGLIDE¿ NEEDLE BEFORE USE. 900 NEEDLES FROM LOT# 9226357, 500 FROM 9057787, 300 FROM 8250581, 100 FROM 8228917, 2400 FROM 9193523, 1100 FROM 9162858, AND AN UNSPECIFIED NUMBER OF NEEDLES FROM LOTS 9093838, 5274755, 6006572, 6152917, AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A LARGE AMOUNT OF NEEDLES THAT ARE RUSTED OUT OF MULTIPLE BOXES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113725 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 SEE SECTION H.10. 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other