BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLE

    MDR report key: 8839222 · Received July 29, 2019

    Report

    Report Number
    1024879-2019-01282
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 12, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMF
    UDI-DI
    50382903686075
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SLEEVE FALL OFF WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SLEEVE FALL OFF WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL: 368607, BATCH NO: 9080851. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE RUBBER SHIELD COMES OFF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RUBBER SHIELD COMES OFF NEEDLE WHILE USING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL: 368607. BATCH NO: 9080851. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE RUBBER SHIELD COMES OFF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RUBBER SHIELD COMES OFF NEEDLE WHILE USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633623 BD ULTRA FINE PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMF BECTON, DICKINSON & CO., (BD) 9080851 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other