BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 20225548 · Received September 16, 2024

    Report

    Report Number
    1911916-2024-00668
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 17, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. ADDITIONAL BATCH REPORTED: BATCH: 3299397 BATCH CREATION DATE: 2023-10-26 BATCH EXPIRATION DATE: 2028-12-31.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THE MEDICATION WILL NOT COME OUT OF THE NEEDLES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBERS 3299397 AND 4103557. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL # 305106 BATCH # 3299397 IT WAS REPORTED BY CUSTOMER THAT THEY HAD DEFECTIVE NEEDLES. VERBATIM: DEFECTIVE NEEDLES ADDITIONAL INFORMATION RECEIVED ON 11-SEP-2024 THE FOLLOWING ARE THE STATEMENTS RECEIVED FROM OUR DEPARTMENTS: ¿WE HAVE HAD PROBLEMS WITH THE 30GX1/2 NEEDLES FROM BD LOT NUMBER 4103557 BEING OCCLUDED AND NOT WORKING RECENTLY FOR OUR DERM PROVIDERS. THANKS.¿ - XXX, MSN, RN ¿TWO NEUROLOGY PROVIDERS (XXX) COMPLAINED THAT SOME OF THE 30 ½ INCH BD PRECISION GLIDE NEEDLES MALFUNCTION WHEN THEY TRY TO ADMINISTER THE BOTOX MEDICATION. THE MEDICATION WILL NOT COME OUT. I APPRECIATE ALL THAT YOU DO.¿ - XXX, MSN, RN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 305106 ; BATCH # 3299397. IT WAS REPORTED BY CUSTOMER THAT THEY HAD DEFECTIVE NEEDLES. ADDITIONAL INFORMATION RECEIVED ON 11-SEP-2024 THE FOLLOWING ARE THE STATEMENTS RECEIVED FROM OUR DEPARTMENTS: ¿WE HAVE HAD PROBLEMS WITH THE 30GX1/2 NEEDLES FROM BD LOT NUMBER 4103557 BEING OCCLUDED AND NOT WORKING RECENTLY FOR OUR DERM PROVIDERS. THANKS.¿ MSN, RN. ¿TWO NEUROLOGY PROVIDERS COMPLAINED THAT SOME OF THE 30 ½ INCH BD PRECISION GLIDE NEEDLES MALFUNCTION WHEN THEY TRY TO ADMINISTER THE BOTOX MEDICATION. THE MEDICATION WILL NOT COME OUT. I APPRECIATE ALL THAT YOU DO.¿ MSN, RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495638 NEEDLE 30X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4103557 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown