BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL

    MDR report key: 11168329 · Received January 13, 2021

    Report

    Report Number
    1213809-2021-00018
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 4, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-01. INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED AND EVALUATED. A LOOSE 3ML SYRINGE WAS DEPICTED IN THE PHOTO. THE PLUNGER ROD WAS OBSERVED TO BE AROUND THE 2ML MARKING. THE STOPPER WAS OBSERVED TO BE SEPARATED FROM THE PLUNGER ROD AND POSITIONED AT AN ANGLE IN THE FLUID PATH. SIX SEALED PACKAGED 3ML SYRINGES WERE RECEIVED, CONFIRMED TO BE FROM BATCH#: 0133147 (P/N: 309658). THE SAMPLES WERE VISUALLY EVALUATED. NO INSECURE OR SEPARATED STOPPERS WERE OBSERVED. THE SAMPLES WERE DISASSEMBLED AND INSPECTED FOR MOLDING AND DAMAGE DEFECTS. NO DEFECTS WERE OBSERVED IN THE RETURNED SAMPLES. SINCE NO MOLDING DEFECTS AND NO DAMAGE WAS OBSERVED IN THE RETURNED PHYSICAL SAMPLES, THE CONDITION OBSERVED IN THE PHOTO WAS LIKELY A RESULT OF AN INSECURE STOPPER. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE PREPPING BD SYRINGE 3ML LL THE STOPPER SEPARATED FROM PLUNGER AND MEDICATION LEAKED PAST THE PLUNGER. THIS OCCURRED ON 4 SEPARATE OCCASIONS, THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: IN THE PHARMACY'S PREPARATION LAB, DURING THE ASPIRATION PHASE OF VIDAZA ( AZACITIDINE ) AND BORTEZOMIB, THE RUBBER GASKET OF THE 3 ML SYRINGE DISCONNECTED FROM THE SYRINGE PLUNGER, RESULTING IN CONTAMINATION OF THE OPERATORS' WORK AREAS AND GLOVES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PREPPING BD SYRINGE 3ML LL THE STOPPER SEPARATED FROM PLUNGER AND MEDICATION LEAKED PAST THE PLUNGER. THIS OCCURRED ON 4 SEPARATE OCCASIONS, THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM(B)(6) TO ENGLISH: IN THE PHARMACY'S PREPARATION LAB, DURING THE ASPIRATION PHASE OF VIDAZA ( AZACITIDINE ) AND BORTEZOMIB, THE RUBBER GASKET OF THE 3 ML SYRINGE DISCONNECTED FROM THE SYRINGE PLUNGER, RESULTING IN CONTAMINATION OF THE OPERATORS' WORK AREAS AND GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54915 BD SYRINGE 3ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0133147 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1