BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 17726155 · Received September 11, 2023

    Report

    Report Number
    1911916-2023-00651
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 26, 2023
    Report Date
    November 20, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS CONTAMINATION IN A FILTER NEEDLE. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS A DROPLET OF EPOXY 3/8" FROM THE TIP OF THE NEEDLE THAT IS 3/32" LONG. 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. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE EPOXY DRIP OVER ON THE NEEDLE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT 9093550. 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 AND ALIGNMENT WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 9093550. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. 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. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    PR (B)(4) NO ADDITIONAL INFORMATION RECEIVED. A COMPLAINT WAS RECEIVED FROM GERMANY REGARDING CONTAMINATION IN FILTER NEEDLE OF BATCH NO. 9093550. C.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ BLUNT FILL NEEDLE WITH FILTER HAD FOREIGN MATTER IN THE FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A COMPLAINT WAS RECEIVED FROM GERMANY REGARDING CONTAMINATION IN FILTER NEEDLE OF BATCH NO. 9093550."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861369 BD¿ BLUNT FILL NEEDLE WITH FILTER NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 9093550 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown