BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21688460 · Received March 25, 2025

    Report

    Report Number
    1911916-2025-00224
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    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

    DEVICE EVALUATION: IT WAS REPORTED THE VIAL RUBBER STOPPERS ARE CORING. AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL # 305180 BATCH # UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT THE VIAL RUBBER STOPPERS ARE CORING/DISLODGING WHEN ATTEMPTING TO ADMINISTER MEDICATIONS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE ARE SEEING A TREND WITH CORING / DISLODGEMENT OF VIAL RUBBER STOPPERS WHEN ATTEMPTING TO ADMINISTER MEDICATIONS. INITIALLY, THE CONCERN WAS FOR THE BLUNT TIP NEEDLES / CANNULAS TYPICALLY USED BY FRONTLINE STAFF TO DRAW UP MEDICATIONS TO BE ADMINISTERED IV. AS WE BEGAN TRACKING OUR REPORTING, WE HAVE SEEN INCONSISTENCIES IN THE DRUG PRODUCTS, MFRS OF NEEDLES AND MEDICATIONS, AS WELL AS VARIANCES AMONG THE ACTUAL PRODUCT DEFECT. THERE HAS BEEN CORING, PUSHING THE ENTIRE STOPPER INTO THE VIAL AND FRAGMENTS / PIECES OF THE STOPPER BREAKING AND FALLING IN. I WILL ATTACH SOME EXAMPLE PICTURES. MEDICATIONS: PROCRIT 10,000U INJ/VIAL, JANSSEN BIOTECH FENTANYL CITRATE PF 50MCG/ML INJ/VIAL, HOSPIRA / PFIZER (MULTIPLE) METHYLPREDNISOLONE, PFIZER CYANOCOBALAMIN, VITAMIN B12 INJ/VIAL, AMERICAN REGENT HEPARIN 10000 UNIT/10ML, INJ, FRESENIUS KABI (MULTIPLE) APREPITANT 130MG/18ML, INJ, HERON THERAPEUTICS, INC. LIDOCAINE WITH EPI (1%), 30ML INJ, UNK CANNULA / NEEDLES: BD NEEDLE 1.5IN 18GA FILL STERILE BLUNT, BD LATEX FREE REF 305180, BD CANNULA INJECTION 17GA BLUNT STERILE LATEX FREE, BD PLASTIC REF 303345, ***, NEDDLELESS MED PREP CANNULAS, REF 8881540111 ****, NEEDLELES MED PREP CANNULAS, REF 8881850310 MEDLINE, 18G HYPODERMIC NEEDLE REF DYNJ60655D, LOT# 24GMA342. (B)(4). REFERENCE REPORT #MW5167115, #MW5167116, #MW5167117, #MW5167118. PRODUCT NUMBER - 305180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093564 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON UNKNOWN 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown