BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 9635091 · Received January 27, 2020

    Report

    Report Number
    1911916-2020-00060
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    January 21, 2020
    Report Date
    January 21, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: THREE PHOTOS WERE PROVIDED. ALL OF THEM ARE SEALED PACKAGING BLISTERS. ONE PHOTO SHOWS A WHITE EPOXY DRIP OVER ON THE NEEDLE. ANOTHER PHOTO SHOWS THE SHIELD WITH NO NEEDLE ASSEMBLY IN IT. THE LAST PHOTO SHOWS A NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD. 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 PHOTOS PROVIDED. THIS IS THE 1ST COMPLAINT FOR LOT # 9093550 FOR MISSING NEEDLE AND PRESENCE OF GLUE ON THE NEEDLE. THIS IS THE 2ND COMPLAINT FOR LOT # 9093550 FOR SHIELD MISSING. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR. THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE SILICONE TO ATTACH THEM. THEN THE PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE THE PLASTIC SHIELD AND/OR NEEDLE WAS NOT ASSEMBLED TO THE PART AND NOT DETECTED IN THE NEXT PROCESS. FOR THE EPOXY DRIP IT IS LIKELY THAT A JAM OCCURRED AT THE CANNULATOR AND THE EQUIPMENT DISPENSED SILICONE BEFORE THE PART WAS MOVED TO THE NEXT STATION AND IT WAS NOT DETECTED IN THE NEXT PROCESS. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "GLUE" WAS FOUND ON THE BD¿ BLUNT FILL NEEDLE WITH FILTER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I¿M WRITING TO INFORM YOU THAT DURING THE MANUFACTURING ACTIVITIES WE HAVE FOUND THE FOLLOWING NON CONFORMITIES ON BLUNT FILL NEEDLES ¿ FILTER 18G X 1 ½ CODE K272200 BATCH 9093550 (INTERNAL BATCH P19104832): MISSING CAP. MISSING NEEDLE. PRESENCE OF GLUE ON THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98283 BD¿ BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 9093550 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other