BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 9495419 · Received December 19, 2019

    Report

    Report Number
    1213809-2019-01279
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    October 19, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 3059052; BATCH NO.: 9232451. IT WAS REPORTED THAT TWO PATIENTS HAD TO BE RE-VACCINATED DUE TO LEAKAGE OF VACCINE AT THE BASE OF THE NEEDLE. PER SALESFORCE PIR: "TWO PATIENTS" THAT HAD TO BE RE-VACCINATED DUE TO LEAKAGE OF VACCINE AT BASE OF NEEDLE. WE DID COMPLETE THE MEDICAL DEVICE AEQUESTER FORM WITHIN THE SERS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 3059052 BATCH NO.: 9232451. IT WAS REPORTED THAT TWO PATIENTS HAD TO BE RE-VACCINATED DUE TO LEAKAGE OF VACCINE AT THE BASE OF THE NEEDLE. PER SALESFORCE PIR: "TWO PATIENTS" THAT HAD TO BE RE-VACCINATED DUE TO LEAKAGE OF VACCINE AT BASE OF NEEDLE. WE DID COMPLETE THE MEDICAL DEVICE AEQUESTER FORM WITHIN THE SERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294533 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305902 9232451 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other