BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 8156706 · Received December 12, 2018

    Report

    Report Number
    1213809-2018-00871
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 6, 2018
    Report Date
    March 1, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MULTIPLE PHOTOS AND TWO 10ML SYRINGES IN OPENED PACKAGES, CONFIRMED TO BE FROM BATCH #8123908 (P/N 300912) WERE RECEIVED AND VISUALLY EVALUATED. BOTH SYRINGES¿ BARRELS HAD MISSING PRINT IN SPOTS OF MUCH OF THEIR PRINTED SCALE MARKINGS THAT INCLUDED THE GRADUATED LINES AS WELL AS SOME OF THE NUMBER MARKINGS. NO SCRATCH MARKS WERE OBSERVED UNDER MAGNIFICATION OF THE BARRELS. THE AMOUNT OF PRINT MISSING WAS MORE THAN 50% OF AT LEAST ONE ITEM, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. 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 THE BD SYRINGE LUER-LOK¿ TIP HAD INCORRECT SCALE MARKINGS AND SCRATCHES ON THEM.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE BD SYRINGE LUER-LOK¿ TIP HAD INCORRECT SCALE MARKINGS AND SCRATCHES ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997935 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8123908 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other