BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB

    MDR report key: 9425918 · Received December 6, 2019

    Report

    Report Number
    1213809-2019-01226
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 14, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059240
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO 3ML SYRINGES WITH SAFETYGLIDE NEEDLE ASSEMBLIES ATTACHED IN OPENED BLISTER PACKS (P/N 305924) WERE RECEIVED AND EVALUATED. ONE BLISTER PACK WAS FROM BATCH 7093912 AND ONE WAS FROM BATCH 7093907. IT WAS OBSERVED IN BOTH SYRINGES, THE END OF THE PLUNGER RODS WERE BROKEN OFF INSIDE THE STOPPER AND WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD 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 THAT SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB PLUNGER DETACHED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305924 BATCH NO. 7093912. IT WAS REPORTED THAT THE PLUNGER DETACHED FROM THE BLACK RUBBER. PER EMAIL FROM CUSTOMER: PLUNGER DETACHED FROM THE BLACK RUBBER AFTER DRAWING UP VACCINE. PLUNGER IS LOOSE AND SLIDES TO END OF SYRINGE. THIS IS THE SECOND ONE IN A WEEK BUT FROM A DIFFERENT BOX. NO OTHERS IDENTIFIED IN THE BOX.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB PLUNGER DETACHED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305924 BATCH NO. 7093912. IT WAS REPORTED THAT THE PLUNGER DETACHED FROM THE BLACK RUBBER. PER EMAIL FROM CUSTOMER: PLUNGER DETACHED FROM THE BLACK RUBBER AFTER DRAWING UP VACCINE. PLUNGER IS LOOSE AND SLIDES TO END OF SYRINGE. THIS IS THE SECOND ONE IN A WEEK BUT FROM A DIFFERENT BOX. NO OTHERS IDENTIFIED IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229122 SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305924 7093912 30382903059240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other