BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 17703275 · Received September 7, 2023

    Report

    Report Number
    1911916-2023-00639
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 16, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS EXCESSIVE GLUE ON THE HUB OF THE NEEDLE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS SIX NEEDLE ASSEMBLIES WITH AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, 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, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE EPOXY DRIP OVER ON THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303005, LOT 3083684. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1911916-2023-00639 WAS SENT IN ERROR. FOREIGN MATTER VISIBLE ON NONINVASIVE COMPONENTS OF NEEDLE (HUB, NEEDLE SHIELD) IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. MFR#: 1911916-2023-00639 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS EXCESSIVE GLUE ON THE HUB OF THE NEEDLE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS SIX NEEDLE ASSEMBLIES WITH AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, 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, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE EPOXY DRIP OVER ON THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303005, LOT 3083684. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 OF THE BD PRECISIONGLIDE¿ NEEDLE HAS EPOXY ON THE NEEDLE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: REASON OF REJECTION: EXCESSIVE GLUE ON HUB OF NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 OF THE BD PRECISIONGLIDE¿ NEEDLE HAS EPOXY ON THE NEEDLE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: REASON OF REJECTION: EXCESSIVE GLUE ON HUB OF NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 OF THE BD PRECISIONGLIDE¿ NEEDLE HAS EPOXY ON THE NEEDLE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: REASON OF REJECTION: EXCESSIVE GLUE ON HUB OF NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101819 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 3083684

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown