BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 18G X 1 ½

    MDR report key: 13479921 · Received February 7, 2022

    Report

    Report Number
    MW5107279
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    February 3, 2022
    Report Date
    April 4, 2022
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 3/25/2022 FOR REPORT MW5107279; A 2022 REPORT FROM ECRI DESCRIBED A POTENTIAL HAZARD WHERE BD - 50 ML SYRINGES MAY CONTAIN DEBRIS. ACCORDING TO THE REPORT, MULTIPLE PHARMACY TECHNICIANS HAVE NOTICED THE DEBRIS, BUT LOT NUMBERS WERE NOT RECORDED. THIS INFORMATION WAS SHARED WITH PHARMACY COMPOUNDING PERSONNEL AT HEALTHCARE. ON "X/X/2022," PHARMACY PERSONNEL AT HOSPITAL OF CENTRAL (A HEALTHCARE FACILITY) NOTICED DEBRIS IN A BO - 10 ML SYRINGE UPON DRAWING UP A MEDICATION. THE DEBRIS WAS NOT SEEN IN THE VIAL PRIOR TO WITHDRAWING, WAS SEEN IN THE SYRINGE, AND IT WAS SEEN IN THE PREPARED FINAL PRODUCT WHICH WAS THEN DISCARDED. WRAPPER AND SYRINGE WERE NOT SAVED. THIS INFORMATION WAS SHARED ACROSS HEALTHCARE. THIS WAS REPORTED TO BD AND FDA MEDWATCH. ON "X/X/2022", PHARMACY PERSONNEL AT MEDICAL CENTER (A HEALTHCARE FACILITY) NOTICED DEBRIS IN A BD 18 G 1 ½ IN NEEDLE HUB. THE NEEDLE WAS NOT USED FOR MEDICATION PREPARATION. THE SYRINGE AND OVER WRAPPER WAS SAVED. PRODUCT NAME: BO PRECISIONGLIDE NEEDLE 18G X 1 ½ REF 305196, LOT 1120195. THIS INFORMATION WAS SHARED ACROSS HEALTHCARE. THIS WAS REPORTED TO BO AND FDA MEDWATCH. COMMUNICATION RELATED TO THE POSSIBILITY OF DEBRIS IN STERILE PRODUCT EQUIPMENT INCREASED AWARENESS AND STAFF DILIGENCE PREVENTED USE OF EQUIPMENT WITH DEBRIS FOR THE COMPOUNDING OF STERILE MEDICATION. CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6).

    Description of Event or Problem · 0

    WHEN REMOVING SYRINGE FROM WRAPPER UNDER ISO5 CONDITIONS, THE PHARMACY TECHNICIAN NOTED DEBRIS WITHIN THE NEEDLE HUB AND DID NOT USE THE PRODUCT. FDA SAFETY REPORT ID # (B)(4).

    Description of Event or Problem · 0

    WHEN REMOVING SYRINGE FROM WRAPPER UNDER ISO5 CONDITIONS, THE PHARMACY TECHNICIAN NOTED DEBRIS WITHIN THE NEEDLE HUB AND DID NOT USE THE PRODUCT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89878 BD PRECISIONGLIDE NEEDLE 18G X 1 ½ NEEDLE, HYPODERMIC, SINGLE LUMEN FMF BD REF 305196 LOT 1120195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown