BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T U100 25G 1IN

    MDR report key: 11668579 · Received April 14, 2021

    Report

    Report Number
    1213809-2021-00227
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1ML S/T U100 25G 1IN HAD FOREIGN MATTER BEFORE USE/DEFORMED STOPPER AND MOLDING DEFECT. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SYRINGE PACKAGES WERE EMPTY AND THE RUBBER WAS MELTED INTO THE CANNULA. VERBATIM: COMPLAINT REPORTED BY BD REP. WIFE WORKS AT VACCINE CENTER IN BALTIMORE. THEY HAVE FOUND MANY EMPTY SYRINGE PACKETS & SYRINGES WITH RUBBER MELTED UP INTO CANNULA. FACILITY HAS HAD TO THROW OUT HUNDREDS." D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 5/14/2021. H6: IMDRF ANNEX A GRID: A0504/A180104/A0406. H6: INVESTIGATION: ONE SEALED EMPTY PACKAGE AND ONE 1ML SYRINGE (P/N 329622) INSIDE AN OPEN PACKAGE FROM BATCH 0150724 WERE RECEIVED AND EVALUATED. THE EMPTY PACKAGE WAS COMPLETELY SEALED AND HAD NO PRODUCT INSIDE OF IT. IT WAS OBSERVED THAT THE STOPPER ON THE SYRINGE WAS SEPARATED FROM THE PLUNGER ROD AND JAMMED AGAINST THE BARREL WALL BETWEEN THE 20 AND 30 UNIT GRAD LINES. THE INTERIOR OF THE SYRINGE BARREL BETWEEN THE MENTIONED GRAD LINES CONTAINED STRESS MARKS AND A VISIBLE OUTWARD BULGE IN THE PRINT AREA. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE BARREL DAMAGE LIKELY AFFECTED ITS ASSEMBLY WITH THE STOPPER. THE WALL DEFORMITY ALIGNED WITH THE LOCATION WHERE THE STOPPER WAS JAMMED. POTENTIAL ROOT CAUSE FOR THE EMPTY PACKAGE DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1ML S/T U100 25G 1IN HAD FOREIGN MATTER BEFORE USE/DEFORMED STOPPER AND MOLDING DEFECT. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SYRINGE PACKAGES WERE EMPTY AND THE RUBBER WAS MELTED INTO THE CANNULA. VERBATIM: COMPLAINT REPORTED BY BD REP. WIFE WORKS AT VACCINE CENTER IN BALTIMORE. THEY HAVE FOUND 1) MANY EMPTY SYRINGE PACKETS & 2) SYRINGES WITH RUBBER MELTED UP INTO CANNULA. FACILITY HAS HAD TO THROW OUT HUNDREDS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1ML S/T U100 25G 1IN HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SYRINGE PACKAGES WERE EMPTY AND THE RUBBER WAS MELTED INTO THE CANNULA. VERBATIM: COMPLAINT REPORTED BY BD REP. WIFE WORKS AT VACCINE CENTER IN BALTIMORE. THEY HAVE FOUND 1) MANY EMPTY SYRINGE PACKETS & 2) SYRINGES WITH RUBBER MELTED UP INTO CANNULA. FACILITY HAS HAD TO THROW OUT HUNDREDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560700 SYRINGE 1ML S/T U100 25G 1IN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0150724

    Patients

    Seq Age Sex Outcome Treatment
    1