BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE LUER-LOK

    MDR report key: 8323237 · Received February 8, 2019

    Report

    Report Number
    1213809-2019-00161
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 18, 2019
    Report Date
    April 15, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO WAS RECEIVED DISPLAYING TWO LOOSE SYRINGES NEXT TO OPENED BLISTER PACKS OF BATCH #8210545 (P/N 309658). ONE OF THE PICTURES RECEIVED SHOWS THE SCALE OF THE SYRINGE SLIGHTLY OUT OF CENTER. 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 THE ROOT CAUSE OF DEFECT FOUND -SCALE MISPLACED/ROLLED SCALE- IS RELATED TO THE PRINTING PROCESS. IT IS POSSIBLE THAT THIS DEFECT OCCURRED DURING THE SETUP OF THE PRINTER MACHINE AND IT IS POSSIBLE THAT LIMITED NUMBER OF SYRINGES WERE NOT PROPERLY REMOVED FROM THE PROCESS ¿ SCRAPPED. THE PERFORMANCE OF THE PRODUCT SHOULD NOT BE COMPROMISED BY ROLLED SCALE, THIS IMPERFECTION DOES NOT COMPROMISE THE PRODUCT¿S VOLUMETRIC ACCURACY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PLASTIPAK¿ SYRINGES LUER-LOK¿S HAD THE "ML-SCALE PRINTED ON THE LATERAL SIDE".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 AN UNSPECIFIED NUMBER OF BD PLASTIPAK SYRINGES LUER-LOKS HAD THE "ML-SCALE PRINTED ON THE LATERAL SIDE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112379 BD PLASTIPAK SYRINGE LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other