BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE LUER-LOK TIP

    MDR report key: 9273790 · Received November 4, 2019

    Report

    Report Number
    1213809-2019-01103
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 7, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO AND FOUR 5ML SYRINGES IN BLISTER PACKS FROM BATCH 9200385 (P/N 309649) WERE RECEIVED AND EVALUATED. THREE OF THE PACKS WERE FULLY SEALED AND ONE WAS OPENED. IT WAS OBSERVED ON ALL FOUR SYRINGES THERE WERE INK CONTACT SMEARS WITH EACH SYRINGE CONTAINING AT LEAST ONE INK SPOT LARGER THAN LEVEL 4 IN SIZE AND WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE INK SMEARS DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT IS POSSIBLE THE BARRELS MADE CONTACT SHORTLY AFTER BEING PRINTED. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9200385 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A BD 5ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THIS BATCH 4/13 PCE SAMPLE THERE IS PRINTING INK AROUND THE SYRINGES."

    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 SCALE MARKING ISSUES WERE FOUND BEFORE USE WITH A BD 5ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IN THIS BATCH 4/13 PCE SAMPLE THERE IS PRINTING INK AROUND THE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070804 BD 5ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9200385 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other