BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 10631894 · Received October 5, 2020

    Report

    Report Number
    1911916-2020-00933
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 8090621. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD AND A DROP OF EPOXY OVER THE PLASTIC NEEDLE HUB. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE ASSEMBLY PROCESS. THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB USING WHITE EPOXY TO FIX IT. IN THIS CASE, A JAM MAY HAVE OCCURRED INDUCING THE WHITE EPOXY DROP OVER THE NEEDLE PLASTIC HUB. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: 1 PHOTO WAS PROVIDED. IT SHOWS A NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD. THE PHOTO SHOWS A DROP OF EPOXY OVER THE PLASTIC NEEDLE HUB. A REVIEW OF THE APPLICABLE FMEA/EURA ((B)(4)) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE DESCRIPTION: NIP ASSEMBLY LINE. 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 THAT, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE WHITE EPOXY DRIP OVER ON THE NEEDLE PLASTIC HUB. RATIONALE: BASED ON THE INVESTIGATION CARRIED OUT AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THIS LOT AND SYMPTOM. THIS LOT WAS PRODUCED FOR 1.9 MM UNITS; THEREFORE, THE CPM IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE BD¿ BLUNT FILL NEEDLE WITH FILTER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THERE WAS A WHITE FOREIGN PARTICLE ON THE SURFACE OF THE CANNULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089660 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 8090621 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other