BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18GA X 1 1/2IN BD¿ BLUNT FILL NEEDLE

    MDR report key: 6836675 · Received August 31, 2017

    Report

    Report Number
    1911916-2017-00239
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    July 25, 2017
    Report Date
    December 12, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE SAMPLE WAS RETURNED. THERE WAS INSUFFICIENT EPOXY ON THE CANNULA. EPOXY IS THE ADHESIVE THAT BINDS THE NEEDLE HUB AND CANNULA TOGETHER. THE PROBABLE ROOT CAUSES OF THE FAILURE MODE WERE: ¿ INSUFFICIENT EPOXY APPLIED DURING CANNULATION. ¿ THE EPOXY INSPECTION CAMERA FAILED TO DETECT IT. ¿ THE REJECT FINGERS FAILED TO REMOVE IT. CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: ASSEMBLY BATCH 7060508 HAD 128 VISUAL INSPECTION PERFORMED ON 6,400 PARTS WITH ZERO DEFECTS OR ISSUES NOTED FOR EPOXY APPLICATION. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. FDA NOTIFIED - YES: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON VIA MEDSUN REPORT #(B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI#: (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT CORRECTION: THE DATE OF EVENT FIELD HAS BEEN UPDATED TO REFLECT THE CORRECTED DATE OF (B)(6) 2017 TO COINCIDE WITH THE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSUMER THAT THE NEEDLE DETACHED FROM THE HUB ON AN 18 G X 1 1/2 IN. BD¿ BLUNT FILL NEEDLE PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616897 18GA X 1 1/2IN BD¿ BLUNT FILL NEEDLE HYPODERMIC FILL NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7059524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other