BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 7/8IN BSG CLEAR HUB

    MDR report key: 18884761 · Received March 12, 2024

    Report

    Report Number
    1911916-2024-00172
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    December 20, 2023
    Report Date
    May 2, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903028905
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLE IS CLOGGED. TO AID IN THE INVESTIGATION, THREE SAMPLES WITH NO PACKAGING BLISTERS AND FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION; EACH NEEDLE EXPELLED THE SOLUTION WITH A NORMAL FLOW. THE PHOTOS SHOW THE INSIDE OF A NEEDLE HUB LOOKING FROM THE BOTTOM UP. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302890, LOT 3052475. 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

    (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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLE IS CLOGGED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW THE INSIDE OF A NEEDLE HUB LOOKING FROM THE BOTTOM UP. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302890, LOT 3052475. 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. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 302890 LOT#:3052475 IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED OVER THE LAST FEW MONTHS WE HAVE HAD SEVERAL COMPLAINTS REGARDING PN 302890 (SPECIFICALLY FROM PO 106451) BEING CLOGGED BY THE END USER. WE WOULD APPRECIATE IF SOMEONE COULD LOOK INTO THIS ISSUE.

    Description of Event or Problem · 0

    MATERIAL#: 302890 LOT#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER ADDITIONAL INFORMATION: THE LOT IS 3052475. THERE HAVE BEEN NO REPORTED ADVERSE EVENTS,

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 302890, LOT#:3052475. IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OVER THE LAST FEW MONTHS WE HAVE HAD SEVERAL COMPLAINTS REGARDING PN 302890 (SPECIFICALLY FROM (B)(4)) BEING CLOGGED BY THE END USER. WE WOULD APPRECIATE IF SOMEONE COULD LOOK INTO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029254 NEEDLE 30GA 7/8IN BSG CLEAR HUB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3052475 50382903028905

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown