BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB NS

    MDR report key: 18928715 · Received March 19, 2024

    Report

    Report Number
    1911916-2024-00192
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903030052
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 NEEDLE PUNCTURED THE OUTER CAP. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE NEEDLE TIP IS THROUGH THE PLASTIC SHIELD. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. THE NEEDLE SHOULD NOT BE RECAPPED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303005, LOT 3181344. 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 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 RECEIVED. MATERIAL #:303005, BATCH#:3181344. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE NEEDLE PUNCTURED THE OUTER CAP. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER: (B)(4). EVENT DATE: 03-07-24. PRODUCT MALFUNCTION/FAILURE MODE: ASSEMBLY ERROR. PRODUCT DESCRIPTION SUMMARY: NEEDLE PUNCTURED THE OUTER CAP. MFG. SKU NUMBER: (B)(4). COMPONENT NAME: NDL,HYPODERMIC,18GX1-1/2IN,REGBEVEL,PINK,NS. INVESTIGATED COMPONENT LOT NUMBER: 3181344.

    Description of Event or Problem · 0

    MATERIAL #:303005 AND BATCH#:3181344. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE NEEDLE PUNCTURED THE OUTER CAP. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER: (B)(4). EVENT DATE: 03-07-24. PRODUCT MALFUNCTION/FAILURE MODE: ASSEMBLY ERROR. PRODUCT DESCRIPTION SUMMARY: NEEDLE PUNCTURED THE OUTER CAP. MFG. SKU NUMBER: 303005. COMPONENT NAME: NDL,HYPODERMIC,18GX1-1/2IN,REGBEVEL,PINK,NS. INVESTIGATED COMPONENT LOT NUMBER: 3181344.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553605 NEEDLE 18X1-1/2 RB NS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3181344 50382903030052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown