BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL W/TWINPAK DEVICE

    MDR report key: 11742482 · Received April 28, 2021

    Report

    Report Number
    1213809-2021-00274
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 19, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903033936
    PMA / PMN Number
    K974006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A LARGE BOX WAS RECEIVED. THE BOX CONTAINED A LOOSE 10ML TWINPAK SYRINGE HALF-FILLED WITH CLEAR MEDICATION IN A ZIP LOCK BAG, ONE USED MEDICATION VIAL WITH SOME MEDICATION IN IT AND LABELED ¿TENECTEPLASE,¿ AND ONE EMPTY SMALL PACKAGING KIT THAT LISTED THE ABOVE TWO ITEMS IN IT. SINCE THE SAMPLES WERE CONTAMINATED ON ARRIVAL, THEY WERE EVALUATED VISUALLY THROUGH THE BAGS ONLY. THE SYRINGE WAS OBSERVED TO HAVE A HUB OF THE RED SYRINGE FILLING DEVICE (SFD) ATTACHED. THERE WAS NO CANNULA PRESENT IN THE SYRINGE FILLING DEVICE (SFD). IT APPEARED TO HAVE BEEN SHEARED OFF FROM THE HUB AS EVIDENCED BY DEFORMATIONS AT THE TIP OF THE HUB. THE VIAL HAD MULTIPLE PIERCING MARKS WHERE IT WAS PUNCTURED BY A NEEDLE. NO CANNULA WAS OBSERVED IN THE VIAL, SYRINGE, NOR ANY BAGS RECEIVED. IT IS POSSIBLE THERE WAS AN ISSUE WITH CANNULA LUBRICATION OR DAMAGE TO THE SYRINGE FILLING DEVICE(SFD), AS IT IS ALSO POSSIBLE THAT USER ERROR WHILE USING THE DEVICE CONTRIBUTED TO THE FAILURE. BASED ON THE SAMPLES RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE WHAT MAY HAVE HAPPENED TO THE SYRINGE FILLING DEVICE'S (SFD) CANNULA. PART OF THE SYRINGE FILLING DEVICE(SFD) WAS MISSING FROM THE SAMPLES RECEIVED WHICH COULD HAVE PROVIDED A MISSING CLUE. THERE WERE ALSO NO UNUSED PACKAGED SAMPLES FROM THE SAME LOT RECEIVED FOR EVALUATION OF ANY POTENTIAL ISSUES. SINCE ROOT CAUSE COULD NOT BE DETERMINED, CORRECTIVE ACTIONS ARE NOT NECESSARY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML LL W/TWINPAK DEVICE HUB WOULD NOT DETACH FROM THE VIAL OF TNKASE AND THE NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE REPORTER STATED THAT IN THE PROCESS OF DRAWING UP THE DOSE OF TNKASE (TENECTEPLASE) ON 03/29/2021, THE RED HUB WOULD NOT DETACH FROM THE VIAL AND THE NEEDLE BROKE OFF. THE REPORTER STATES THE TNKASE WAS DRAWN UP WITH ANOTHER NEEDLE AND THERE WAS A SLIGHT DELAY IN ADMINISTRATION OF 20 MINS BUT IT WAS GIVEN WITHIN THE TIME FRAME OF 60 MINS." "THE DRUG ADMINISTRATION PROCEDURE WAS DELAYED FOR 20 MINS IN AN EMERGENCY SETTING. TNKASE IS USED IN EMERGENCY SITUATIONS FOR USE IN THE REDUCTION OF MORTALITY ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION (AMI). TREATMENT SHOULD BE INITIATED AS SOON AS POSSIBLE AFTER THE ONSET OF AMI SYMPTOMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632622 SYRINGE 10ML LL W/TWINPAK DEVICE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 303393 9323515 30382903033936

    Patients

    Seq Age Sex Outcome Treatment
    1