BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 18569652 · Received January 24, 2024

    Report

    Report Number
    1911916-2024-00036
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP. IT WAS REPORTED THERE IS A TINY PIN HOLE IN THE SIDE PART OF THE HUB. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW TWO NEEDLE ASSEMBLIES WITH NO PACKAGING BLISTERS OR PLASTIC SHIELDS. ONE NEEDLE ASSEMBLY IS PLACED NINETY DEGREES OPPOSITE THE OTHER NEEDLE WITH THE NEEDLE FROM ONE PLACED OVER THE NEEDLE HUB OTHER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305127, LOT 3209587. 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND WITHOUT THE ACTUAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    PR (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

    ADDITIONAL INFORMATION RECEIVED. YES, THERE IS PATIENT IMPACT. THE LEAK DOES NOT ALLOW THE FULL DOES OF LOCAL ANESTHETIC TO BE GIVEN DURING THE NUMBING PROCESS FOR INJECTION THERAPY. THE FORCES BETWEEN THE SYRINGE AND THE INSERTION INTO THE SKIN CAUSE THE LOCAL TO EJECT FROM THE LEAK LOCATION, DELIVERING ONLY MINIMAL NUMBING TO THE AREA. MATERIAL#: 305127. LOT#: 3209587. IT WAS REPORTED BY THE CUSTOMER REPORTED THAT WE ARE HAVING ISSUES WITH A BUNCH OF OUR 25G 1.5¿ HYPODERMIC NEEDLES. MORE OFTEN THAN NOT THERE IS A TINY PIN HOLE IN THE SIDE (BLUE PLASTIC) PART OF THE HUB. IT IS NOT AROUND WHERE THE NEEDLE ATTACHES BUT THE BLUE PART ITSELF. WE HAVE QUITE A FEW CASES OF THESE AND WERE WONDERING IF THERE IS ANYTHING THAT CAN BE DONE ABOUT THIS. VERBATIM: WE ARE HAVING ISSUES WITH A BUNCH OF OUR 25G 1.5¿ HYPODERMIC NEEDLES. MORE OFTEN THAN NOT THERE IS A TINY PIN HOLE IN THE SIDE (BLUE PLASTIC) PART OF THE HUB. IT IS NOT AROUND WHERE THE NEEDLE ATTACHES BUT THE BLUE PART ITSELF. WE HAVE QUITE A FEW CASES OF THESE AND WERE WONDERING IF THERE IS ANYTHING THAT CAN BE DONE ABOUT THIS.

    Description of Event or Problem · 0

    MATERIAL#: 305127 LOT#: 3209587 IT WAS REPORTED BY THE CUSTOMER REPORTED THAT WE ARE HAVING ISSUES WITH A BUNCH OF OUR 25G 1.5¿ HYPODERMIC NEEDLES. MORE OFTEN THAN NOT THERE IS A TINY PIN HOLE IN THE SIDE (BLUE PLASTIC) PART OF THE HUB. IT IS NOT AROUND WHERE THE NEEDLE ATTACHES BUT THE BLUE PART ITSELF. WE HAVE QUITE A FEW CASES OF THESE AND WERE WONDERING IF THERE IS ANYTHING THAT CAN BE DONE ABOUT THIS. VERBATIM: WE ARE HAVING ISSUES WITH A BUNCH OF OUR 25G 1.5¿ HYPODERMIC NEEDLES. MORE OFTEN THAN NOT THERE IS A TINY PIN HOLE IN THE SIDE (BLUE PLASTIC) PART OF THE HUB. IT IS NOT AROUND WHERE THE NEEDLE ATTACHES BUT THE BLUE PART ITSELF. WE HAVE QUITE A FEW CASES OF THESE AND WERE WONDERING IF THERE IS ANYTHING THAT CAN BE DONE ABOUT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135896 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3209587 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown