BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 19483353 · Received June 7, 2024

    Report

    Report Number
    1911916-2024-00414
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE NEEDLES ARE CAUSING THE RUBBER STOPPERS ON VIALS TO CORE. TO AID IN THE INVESTIGATION, FOUR SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THREE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND THE FOURTH SAMPLE CAME IN AN OPENED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED WITH A 30X MICROSCOPE. THERE WAS NO DAMAGE, DEFECTIVE GRIND OR HOOKS OBSERVED. THE BEVELS AND ETCH WERE GOOD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4031363. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED DATE OF EVENT: 6/3/24 ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO CAN YOU PLEASE BRIEFLY ELABORATE THE PRODUCT DAMAGE. THE VIAL IS BEING CORED BY THE NEEDLE AS IT BEING INJECTED INTO THE RUBBER STOPPER. WAS PENETRATION DIFFICULT DUE TO THE ANGLE OF INSERTION OR DUE TO A PERCEIVED DULLNESS TO THE NEEDLE TIP? YES WAS THERE ANY DAMAGE SUSTAINED TO THE DEVICE DURING USE? IF SO, APPROXIMATELY WHERE? NO DAMAGE TO THE DEVICE BUT DAMAGE TO THE VIAL/DRUG. MATERIAL #:305196 BATCH#: 4031363 IT WAS REPORTED BY CUSTOMER THAT CUST (B)(6) REPORTS THEY HAD 18G NEEDLES (B-D305196Z) CAUSING THE RUBBER STOPPERS ON VIALS TO CORE. CUST HAS SET ASIDE 14 BX FROM LOT # 4031363 WITH THIS ISSUE. CUST IS REQUESTING CREDIT AND CAN SEND BACK THE AFFECTED LOT. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO MEDLINE REFERENCE #: (B)(4) ITEM: 305196, QUANTITY AFFECTED: (B)(4), SERIAL/LOT NUMBER: 4031363, PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE PER CUSTOMER: CUST MEGAN EICKHOLT REPORTS THEY HAD 18G NEEDLES (B-D305196Z) CAUSING THE RUBBER STOPPERS ON VIALS TO CORE. CUST HAS SET ASIDE 14 BX FROM LOT # 4031363 WITH THIS ISSUE. CUST IS REQUESTING CREDIT AND CAN SEND BACK THE AFFECTED LOT.

    Description of Event or Problem · 0

    MATERIAL #:305196 BATCH#: 4031363. IT WAS REPORTED BY CUSTOMER THAT CUST MEGAN EICKHOLT REPORTS THEY HAD 18G NEEDLES (B-D305196Z) CAUSING THE RUBBER STOPPERS ON VIALS TO CORE. CUST HAS SET ASIDE 14 BX FROM LOT # 4031363 WITH THIS ISSUE. CUST IS REQUESTING CREDIT AND CAN SEND BACK THE AFFECTED LOT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE #: (B)(4). ITEM: 305196 QUANTITY AFFECTED: (B)(4) BX. SERIAL/LOT NUMBER: (B)(6) . PO #: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: CUST MEGAN EICKHOLT REPORTS THEY HAD 18G NEEDLES (B-D305196Z). CAUSING THE RUBBER STOPPERS ON VIALS TO CORE. CUST HAS SET ASIDE 14 BX FROM LOT # 4031363 WITH THIS ISSUE. CUST IS REQUESTING CREDIT AND CAN SEND BACK THE AFFECTED LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151351 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4031363 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown