BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 23X1 RB MCK

    MDR report key: 11091469 · Received December 29, 2020

    Report

    Report Number
    1213809-2020-00927
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    November 25, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248554
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE SFTYGLD 23X1 RB MCK EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306610, BATCH NO: 0141219. DURING A ROUTINE FLU VACCINATION ADMINISTRATION, A SAFETY NEEDLE WAS USED. ADMINISTRATION COMPLETED WITHOUT AN ISSUE, HOWEVER, ONCE THE NEEDLE WAS ATTEMPTED TO BE RETRACTED FROM THE PATIENTS SKIN, THE PROVIDER REPORTED THE FOLLOWING: "[I] WAS ABLE TO GIVE THE VACCINE BUT WHEN PULLING OUT THE NEEDLE, IT REMAINED IN THE PATIENTS SKIN STICKING FROM THE RIGHT THIGH. I WAS ABLE TO PULL THE NEEDLE OUT WITH MY HAND WITH NO INJURY OR HARM TO THE PATIENT". WE HAD A SAFETY NEEDLE SEPARATE FROM THE ASSEMBLY AND REMAIN IN THE PATIENT DURING A ROUTINE FLU VACCINATION ADMINISTRATION.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: ONLY THE PATIENT'S AGE WAS PROVIDED, THEREFORE A DEFAULT DATE OF BIRTH HAS BEEN LISTED A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE SFTYGLD 23X1 RB MCK EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306610, BATCH NO: 0141219. DURING A ROUTINE FLU VACCINATION ADMINISTRATION, A SAFETY NEEDLE WAS USED. ADMINISTRATION COMPLETED WITHOUT AN ISSUE, HOWEVER, ONCE THE NEEDLE WAS ATTEMPTED TO BE RETRACTED FROM THE PATIENTS SKIN, THE PROVIDER REPORTED THE FOLLOWING: "[I] WAS ABLE TO GIVE THE VACCINE BUT WHEN PULLING OUT THE NEEDLE, IT REMAINED IN THE PATIENTS SKIN STICKING FROM THE RIGHT THIGH. I WAS ABLE TO PULL THE NEEDLE OUT WITH MY HAND WITH NO INJURY OR HARM TO THE PATIENT". WE HAD A SAFETY NEEDLE SEPARATE FROM THE ASSEMBLY AND REMAIN IN THE PATIENT DURING A ROUTINE FLU VACCINATION ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557303 NEEDLE SFTYGLD 23X1 RB MCK NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 192-N231S 0141219 10612479248554

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR