BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® MULTIPLE USE DRAWING NEEDLE 22G X 1 1/4" BLACK, STERILE

    MDR report key: 15699775 · Received October 31, 2022

    Report

    Report Number
    8020040-2022-00034
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Report Date
    November 28, 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 5PCS 450061/21J29D FOR EVALUATION. NO CUSTOMER 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 THE PRODUCTS. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED MATERIAL/BATCH WERE REVIEWED, AND NO ABNORMALITIES WHICH COULD BE RELATED TO THE REPORTED ISSUE WERE OBSERVED. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY EXAMINED. NO ABNORMALITIES SUCH AS DAMAGE WERE FOUND. THE RIGIDITY OF THE NEEDLE TUBES WAS TESTED; ALL WERE WITHIN THE RANGE OF STANDARDS. THE ALLEGED MALFUNCTION CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE ONLY RECENTLY RECEIVED AND FORWARDED TO THE SUPPLIER, WHERE WE PURCHASE THE DEVICE FROM. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER ADVISED THEY WERE STUCK WITH THE NEEDLE WHEN THE GREEN CAP SNAPPED OFF AS THEY WERE GOING TO CLOSE IT, POKING THEIR MIDDLE FINGER. HERE IS THE UPDATED INFORMATION FROM THE CUSTOMER AND THE MDR QUESTIONNAIRE RESPONSES FOR THIS COMPLAINT. THE CUSTOMER LEFT QUESTION #5 BLANK. 1. WAS THE NEEDLE STICK LIFE THREATENING? NO. 2. DID THE NEEDLE STICK RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION? NO. 3. DID THE NEEDLE STICK RESULT IN PERMANENT DAMAGE TO A BODY STRUCTURE? NO. 4. DID THE NEEDLE STICK NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE? NO. 5. CAN YOU PROVIDE THE GREINER ITEM NUMBER(S) AND LOT NUMBER(S) INVOLVED? 6. CAN YOU PROVIDE THE FULL NAME AND ADDRESS OF THE LOCATION WHERE THE NEEDLESTICK OCCURRED, AND A CONTACT PERSON? (B)(6), KALA JURNO CONTACT PERSON (RN LEAD). 7. CAN YOU PROVIDE A FULL DESCRIPTION OF HOW THE NEEDLESTICK(S) OCCURRED? WHILE PUSHING GREEN SAFETY COVER IT SNAPPED OFF CAUSING NEEDLE TO POKE HER FINGER. 8. DID THE FACILITY RECEIVE PRODUCT TRAINING FROM A GREINER PRODUCT SPECIALIST? YES. 9. DO YOU HAVE ANY UNUSED PRODUCT SAMPLES AVAILABLE FOR RETURN TO GREINER FOR A QUALITY INVESTIGATION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328396 VACUETTE® MULTIPLE USE DRAWING NEEDLE 22G X 1 1/4" BLACK, STERILE CANNULA, NEEDLE FMI GREINER BIO-ONE GMBH 450061 21J29D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown