BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 18669461 · Received February 8, 2024

    Report

    Report Number
    1911916-2024-00069
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    February 5, 2024
    Report Date
    February 28, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THE INFORMATION REGARDING THE SECOND BATCH NUMBER PROVIDED WAS INADVERTENTLY OMITTED. 2ND BATCH: 3055142 - EXPIRATION DATE: 2028-04-30.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE IS A WHITE SUBSTANCE BETWEEN THE NEEDLE AND WHERE THE NEEDLE INSERTS TO THE HUB. TO AID IN THE INVESTIGATION, FOUR SAMPLES IN OPENED PACKAGING BLISTERS AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THREE SAMPLES WERE FROM LOT 3055142 AND ONE SAMPLE WAS FROM LOT 3181367. A VISUAL INSPECTION WAS PERFORMED. LOT 3181367 HAD NO DEFECTS OR IMPERFECTIONS. TWO SAMPLES FROM LOT 3055142 HAVE NO DEFECTS OR IMPERFECTIONS, AND ONE SAMPLE HAS AN EPOXY DRIP OVER ON THE NEEDLE HUB. THE TWO PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EPOXY DRIP OVER COULD OCCUR DURING THE ASSEMBLY PROCESS IF THERE IS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305916, LOTS 3055142 AND 3181367. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIALS#: 305196 BATCH#: 3055142 & 3181367 IT WAS REPORTED BY THE CUSTOMER THAT WHITE SUBSTANCE BETWEEN THE NEEDLE AND WHERE THE NEEDLE INSERTS TO THE HUB. IT SEEMS TO BE ON MULTIPLE NEEDLES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OCCURRENCE ID: F8EBDDFD PATIENT NAME: NO PATIENT VISIT NUMBER: OCCURRENCE DATE: 2/5/2024 OCCURRENCE TIME: 1545 OCCURRENCE DEPARTMENT: ED / EMS EVENT CHOICE: DEFECTIVE DEVICE/SUPPLY MANUFACTURER ITEM CODE: PRECISION GLIDE NEEDLE--18G PRODUCT DESCRIPTION: 18G NEEDLE/REF # 305196 (427) LOT NUMBER: 3055142 & 3181367 QUANTITY: MULTIPLE DESCRIPTION OF EVENT/OVERVIEW OF COMPLAINT: THERE IS A WHITE SUBSTANCE BETWEEN THE NEEDLE AND WHERE THE NEEDLE INSERTS TO THE HUB. IT SEEMS TO BE ON MULTIPLE NEEDLES. AS JEANETTE WAS DRAWING UP THE MEDICATION, THIS WHITE SUBSTANCE DID CHIP OFF. THE MEDICATION WAS DISPOSED OF.

    Description of Event or Problem · 0

    MATERIALS#: 305196, BATCH#: 3055142 & 3181367. IT WAS REPORTED BY THE CUSTOMER THAT WHITE SUBSTANCE BETWEEN THE NEEDLE AND WHERE THE NEEDLE INSERTS TO THE HUB. IT SEEMS TO BE ON MULTIPLE NEEDLES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OCCURRENCE ID: F8EBDDFD PATIENT NAME: NO PATIENT, PATIENT VISIT NUMBER: OCCURRENCE DATE: (B)(6) 2024 OCCURRENCE TIME: 1545 OCCURRENCE DEPARTMENT: ED / EMS EVENT CHOICE: DEFECTIVE DEVICE/SUPPLY MANUFACTURER ITEM CODE: PRECISION GLIDE NEEDLE--18G PRODUCT DESCRIPTION: 18G NEEDLE/REF # 305196 (427) LOT NUMBER: 3055142 & 3181367 QUANTITY: MULTIPLE DESCRIPTION OF EVENT/OVERVIEW OF COMPLAINT: THERE IS A WHITE SUBSTANCE BETWEEN THE NEEDLE AND WHERE THE NEEDLE INSERTS TO THE HUB. IT SEEMS TO BE ON MULTIPLE NEEDLES. AS (B)(6) WAS DRAWING UP THE MEDICATION, THIS WHITE SUBSTANCE DID CHIP OFF. THE MEDICATION WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764237 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3181367 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown