BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP

    MDR report key: 7582380 · Received June 8, 2018

    Report

    Report Number
    1911916-2018-00263
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 17, 2018
    Report Date
    June 27, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. ASSEMBLY BATCH 6153637 HAD 162 VISUAL INSPECTIONS PERFORMED ON 8,050 PARTS WITH ZERO DEFECTS NOTED. THE ID INSPECTION SYSTEM WAS CHALLENGED 81 TIMES USING 2,025 PARTS WITH ZERO FAILURES RECORDED. ASSEMBLY BATCH 6120576 HAD 111 VISUAL INSPECTIONS PERFORMED ON 5,700 PARTS WITH ZERO DEFECTS NOTED. THE ID INSPECTION SYSTEM WAS CHALLENGED 55 TIMES USING 1,375 PARTS WITH ZERO FAILURES RECORDED. ALL INSPECTIONS WERE PERFORMED WITH NO ISSUES NOTED. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THESE BATCHES, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP WAS DIFFICULT TO EXTRACT THE SOLUTION WITH ONE FILTER NEEDLE. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427141 BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP BLUNT/FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 6152796 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other