BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 21675962 · Received March 24, 2025

    Report

    Report Number
    1911916-2025-00219
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 1, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. BATCH: 4247148. BATCH CREATION DATE: 09/03/2024. BATCH EXPIRATION DATE: 11/30/2029. FULL UDI: (B)(4). BATCH: 4212625. BATCH CREATION DATE: 07/30/2024. BATCH EXPIRATION DATE: 09/30/2029. FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. AN EXCESS OF GLUE WAS REPORTED UNDER THE CAP. TO SUPPORT THE INVESTIGATION, TWELVE SAMPLES AND TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES INCLUDED TWO FROM LOT 4247148, NINE FROM LOT 4212625, AND ONE FROM LOT 3347887. TWO SAMPLES FROM LOT 4212625 WERE RECEIVED IN OPENED PACKAGING BLISTERS, WHILE THE REMAINING SAMPLES WERE IN SEALED PACKAGING BLISTERS. UPON VISUAL INSPECTION, THE SAMPLES EXHIBITED AN EPOXY DRIP ON THE NEEDLE HUB. ONE PHOTOGRAPH DEPICTED THREE PACKAGING BLISTER TOP WEBS, AND THE OTHER SHOWED TWO NEEDLE ASSEMBLIES WITHOUT PACKAGING BLISTERS AND WITH THE PLASTIC SHIELD REMOVED; BOTH NEEDLE ASSEMBLIES HAD AN EPOXY DRIP ON THE NEEDLE HUB. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION IS LIKELY TO OCCUR DURING THE ASSEMBLY PROCESS IF THERE IS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 305196, COVERING LOTS 4247148, 4212625, AND 3347887. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR SETTINGS CONFIRMED THEY WERE CORRECT, AND THE PRODUCT FLOW WAS SATISFACTORY. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE SYMPTOM REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THERE WAS EXCESS GLUE FOUND UNDER THE CAP. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS THREE PACKAGING BLISTER TOP WEBS. THE OTHER PHOTO SHOWS TWO NEEDLE ASSEMBLIES WITH NO PACKAGING BLISTERS AND THE PLASTIC SHIELD REMOVED; BOTH NEEDLE ASSEMBLIES HAVE AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION OCCURS DURING THE ASSEMBLY PROCESS IF THERE IS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOTS 4247148, 4212625 AND 3347887. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. 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. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305196, BATCH # 4247148, 4212625, 3347887. VERBATIM: PATIENT HARM: NO. EVENT DESCRIPTION: WHAT THE CUSTOMERS BEST GUESS IS EXCESS GLUE FOUND UNDER CAP OF 18G PRECISION GLIDE NEEDLE IT WAS IDENTIFIED PRIOR TO USE. I DO HAVE SAMPLES PULLED THAT I CAN MAIL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768427 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3347887 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown