BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 21751872 · Received April 2, 2025

    Report

    Report Number
    1911916-2025-00257
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED ONE NEEDLE WAS OBSERVED TO BE DISCOLORED ON THE TOP OF THE NEEDLE, ONE CONTAINED A BLACK MARK, AND ONE APPEARED TO HAVE A PARTICULATE INSIDE. TO AID IN THE INVESTIGATION, THREE SAMPLES IN SEALED PACKAGING BLISTERS AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION, ONE SAMPLE HAS A DARK COLOR SPECK IN THE NEEDLE HUB. IT IS 1/128" IN SIZE, WHICH IS ACCEPTABLE. THE SECOND SAMPLE HAS A DARK COLOR SPECK OF EMBEDDED DEGRADED RESIN AT THE BOTTOM OF THE NEEDLE HUB. THE THIRD SAMPLE HAS A DARK COLORED PARTICLE OF DUST ADHERED TO THE NEEDLE. IT IS ABOUT 3/16" FROM THE TOP PART OF THE NEEDLE HUB AND IS 1/32" IN SIZE. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. THE DUST CONDITION OCCURS IF THE PARTICLE WAS NOT REMOVED DURING CLEANING AFTER REPAIR OR MAINTENANCE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4332696. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS 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

    MATERIAL #305196 LOT #4332696. IT WAS REPORTED BY CUSTOMER THAT DEFECTS WERE IDENTIFIED. ONE NEEDLE WAS OBSERVED TO BE DISCOLORED ON THE TOP OF THE NEEDLE, ONE CONTAINED A BLACK MARK, AND ONE WHICH APPEARED TO HAVE A PARTICULATE INSIDE. RCC RECEIVED A COMPLAINT VIA EMAIL. OUR TEAM REPORTED A SECOND SHIPMENT OF PRECISIONGLIDE NEEDLES (ITEM 305196 BATCH 4332696) WHERE DEFECTS WERE IDENTIFIED. ONE NEEDLE WAS OBSERVED TO BE DISCOLORED ON THE TOP OF THE NEEDLE, ONE CONTAINED A BLACK MARK, AND ONE WHICH APPEARED TO HAVE A PARTICULATE INSIDE. PLEASE SEE THE ATTACHED PHOTOS FOR EXAMPLES. PLEASE PROVIDE ANOTHER RETURN LABEL IF THE SAMPLES SHOULD BE RETURNED FOR INVESTIGATION. THE REASON FOR THE COMPLAINT. DETAILED DESCRIPTION OF THE REPORTED CONDITION (WHAT), WHO IS AFFECTED, HOW IT WAS DETECTED, IMPACT. WITHIN A SAMPLE SIZE OF 500 NEEDLES, 3 WERE FOUND WITH DEFECTS. ONE NEEDLE WAS OBSERVED TO BE DISCOLORED ON THE TOP OF THE NEEDLE, ONE CONTAINED A BLACK MARK, AND ONE WHICH APPEARED TO HAVE A PARTICULATE INSIDE. PHOTOS ARE ATTACHED. THE LOT REMAINS IN QUARANTINE AND HAS NOT BEEN RELEASED FOR USE. THE AQL DEFECT CLASSIFICATION WILL BE DEPENDENT ON THE INVESTIGATION. WHERE THE REPORTED CONDITION WAS DETECTED (INCOMING, PRODUCTION, FINAL INSPECTION, MARKET, QUALIFICATION TRIALS, ) DEFECTS WERE OBSERVED DURING INCOMING AQL INSPECTION. SAMPLE AVAILABILITY (QUANTITY, CONDITION AND SHIPMENT INFORMATION) ¿ 3 UNOPENED NEEDLES ARE AVAILABLE TO BE RETURNED. PLEASE CONFIRM IF SAMPLES CAN BE SHIPPED BACK FOR INVESTIGATION. SHARE COMPLAINT SAMPLE OF ALLEGED DEFECT (IF AVAILABLE) NO GREATER THAN 5 BUSINESS DAYS FROM THE TIME OF COMPLAINT ACKNOWLEDGEMENT ¿ SAMPLES ARE READY TO SHIP, PLEASE PROVIDE RETURN ADDRESS. CERTIFICATION OF DECONTAMINATED BY CUSTOMER (IF APPLICABLE) ¿ NOT APPLICABLE, NEEDLES ARE UNOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745613 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4332696

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown