BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT

    MDR report key: 12849311 · Received November 19, 2021

    Report

    Report Number
    1024879-2021-00815
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 25, 2021
    Report Date
    January 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JTA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H5: IMDRF ANNEX A GRID: A24. H6: INVESTIGATION SUMMARY THE CUSTOMER COMPLAINT ON THEIR VENT AEROBIC 50 EA, (CAT. 249560, LOT 1103444) OF SOME DEVICES IN THE SHELF PACK WITH A LOOSE NEEDLE/CANNULA WHILE IN USE WAS NOT CONFIRMED. NO SAMPLES OR PHOTOS WERE PROVIDED. THE DEVICE HISTORY RECORD REVIEW AND RETAIN SAMPLE ANALYSIS REVEALED NO DEFECTS. A PULL TEST WAS PERFORMED ON A SAMPLE GROUP OF THE LOT RETAINS AND ALL EXCEEDED THE MINIMUM 5 POUND PULL FORCE SPECIFICATION. A REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT DOES NOT INDICATE A TREND FOR THIS ISSUE. NO FURTHER ACTION WILL BE TAKEN AS THIS IS AN ISOLATED INCIDENT. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT THE LABORATORY PERSONNEL HAD THE REAGENT UNDER THEIR SKIN. THE LABORATORY PERSONNEL HAD A SEROLOGY TEST AS A RESULT WHICH CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " A PRICKING PROBLEM WITH OUR SUBCULTURE SYSTEMS APPARENTLY THE TECHNICIAN PRICKED HERSELF WITH OUR SYSTEM AND A SECOND TECHNICIAN ALMOST PRICKED HERSELF THIS WEEKEND"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT THE LABORATORY PERSONNEL HAD THE REAGENT UNDER THEIR SKIN. THE LABORATORY PERSONNEL HAD A SEROLOGY TEST AS A RESULT WHICH CAME BACK NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PRICKING PROBLEM WITH OUR SUBCULTURE SYSTEMS APPARENTLY THE TECHNICIAN PRICKED HERSELF WITH OUR SYSTEM AND A SECOND TECHNICIAN ALMOST PRICKED HERSELF THIS WEEKEND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739336 BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT MONITOR, MICROBIAL GROWTH JTA BECTON, DICKINSON & CO., (BD) 1103444

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention