BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LS 200 S/C

    MDR report key: 9167735 · Received October 8, 2019

    Report

    Report Number
    1213809-2019-01013
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 19, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096566
    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

    INVESTIGATION SUMMARY: TWO PHOTOS AND FIVE 3ML SYRINGES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH 9002521 (P/N 309656). WERE RECEIVED AND EVALUATED. IT WAS OBSERVED TWO OF THE SYRINGES CONTAINED THE SCALE MARKING AND NO GRAD LINES. TWO SYRINGES CONTAINED HALF OF ALL THE SCALE MARKING WITH NO GRAD LINES. ONE SYRINGE WAS NEARLY COMPLETELY BLANK. THE MISSING PRINT OBSERVED WAS REJECTABLE PER PRODUCT SPECIFICATION DURING PRODUCTION OF THE REPORTED BATCH, AN ISSUE WAS IDENTIFIED AND ADDITIONAL MEASURES WERE TAKEN TO ASSURE RELEASE OF THE PRODUCT. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT IS ASSOCIATED WITH THE PRINTING PROCESS. IT IS LIKELY A PRINTING COMPONENT GRADUALLY SLIPPED OUT OF ADJUSTMENT CAUSING THE PRINT TO BE APPLIED ON THE INCORRECT POSITION ON THE BARREL. THIS IS CONSISTENT WITH THE VARIANCE OF THE MISSING SCALE. THE POTENTIAL ROOT CAUSE FOR THE PRODUCT BEING DISTRIBUTED IS ASSOCIATED WITH INSUFFICIENT CONTAINMENT. THE MISSING PRINT WAS DISCOVERED DURING MANUFACTURING AND CONTAINMENT ACTIONS WERE ADMINISTERED BUT DEFECTIVE PRODUCT WAS STILL PACKAGED AND DISTRIBUTED. THE PRINTING COMPONENTS INVOLVED IN THE ROLLED SCALE WERE REPLACED 10/14/2019. FOR INSUFFICIENT CONTAINMENT, CAPA 753644 WAS OPENED AND IMPLEMENTED 8/26/2019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE SYRINGE 3ML LS 200 S/C WAS OBSERVED WITH MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 BOX (309656) MISSING SCALE MARKINGS ON SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, THE SYRINGE 3ML LS 200 S/C WAS OBSERVED WITH MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 BOX (309656) MISSING SCALE MARKINGS ON SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963825 SYRINGE 3ML LS 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9002521 30382903096566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other