BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN NEEDLELESS MED PREP CANNULAS

    MDR report key: 21504089 · Received March 3, 2025

    Report

    Report Number
    MW5167116
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Report Date
    February 27, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    GEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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, COVIDIEN, NEDDLELESS MED PREP CANNULAS, REF 8881540111 COVIDIEN, NEEDLELES MED PREP CANNULAS, REF 8881850310 MEDLINE, 18G HYPODERMIC NEEDLE REF DYNJ60655D, LOT# 24GMA342. (B)(4). REFERENCE REPORT #MW5167114, #MW5167115, #MW5167117, #MW5167118.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147417 COVIDIEN NEEDLELESS MED PREP CANNULAS CANNULA, SURGICAL, GENERAL & PLASTIC SURGER GEA CARDINAL HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown APREPITANT - HERON THERAPEUTICS 130 MG/18 ML | CYANOCOBALAMIN - AMERICAN REGENT INC. | FENTANYL CITRATE PRESERVATIVE FREE - HOSPIRA, INC. 50 MCG/ML | HEPARIN - FRESENIUS KABI USA INC. 10,000 UNITS/10 ML | IRON SUCROSE - AMERICAN REGENT INC. | LIDOCAINE HCL AND EPINEPHRINE 1% 30 ML | LORAZEPAM 2 MG/ML | METHERGINE | METHYLPREDNISOLONE - PFIZER, INC. | PROCRIT - JANSSEN BIOTECH INC. 10,000 UNITS| SOLU-CORTEF - PFIZER, INC. 100 MG PER VIAL