BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION NEEDLE

    MDR report key: 15552606 · Received October 6, 2022

    Report

    Report Number
    8020040-2022-00030
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    August 18, 2022
    Report Date
    November 10, 2022
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4): RECEIVED 300 PCS 450062/21K23D FOR EVALUATION. NO PICTURES WERE PROVIDED. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND CUSTOMER SAMPLES TO OUR SUPPLIER FROM WHICH WE RECEIVE THESE PRODUCTS. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED MATERIAL/BATCH WERE REVIEWED, AND NO ABNORMALITIES COULD BE OBSERVED. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY EXAMINED. NO ABNORMALITIES SUCH AS DAMAGE OR BENT NEEDLES WERE FOUND. THE RIGIDITY OF THE NEEDLE TUBES WAS TESTED; ALL WERE WITHIN THE RANGE OF STANDARDS. THE ALLEGED MALFUNCTION CANNOT BE CONFIRMED. CORRECTED DATA: D4: ADDITIONAL DEVICE INFORMATION; H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). NO SAMPLES, ITEM OR LOT NUMBER WERE RECEIVED FROM THE CUSTOMER. THE INCIDENT WAS REPORTED FOR INVESTIGATION TO THE MANUFACTURER WHERE WE PURCHASE THE PRODUCT FROM. AS SOON AS A RESPONSE IS AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER STATES: NEEDLESTICK AND SAFETY IS FLIMSY AND DID NOT COVER THE NEEDLE. DATE OF INJURY: (B)(6) 2022, GREINER BIO ONE NEEDLE, HOW INJURY OCCURRED: WHILE ENGAGING NEEDLE SAFETY POST VENIPUNCTURE, RT INDEX FINGER SLIPPED OFF THE SAFETY AND ONTO THE NEEDLE, LIFE THREATENING? NO, LIFE THREATENING? NO, PERMANENT DAMAGE? NO, MEDI/SURG INTERVENTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245548 VACUETTE BLOOD COLLECTION NEEDLE CANNULA FMI GREINER BIO-ONE GMBH 450062 21K23D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown