BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 11853057 · Received May 19, 2021

    Report

    Report Number
    1213809-2021-00346
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 24, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/10/2021. H.6. INVESTIGATION: EIGHTY-FOUR 3ML SYRINGES IN FULLY SEALED BLISTER PACKS FROM BATCH 1041510 (P/N 309657) WERE RECEIVED AND EVALUATED. FIVE OF THE SYRINGES HAD NO VISIBLE DEFECTS. SEVENTY-NINE OF THE SYRINGES HAD VARYING DEGREES OF MISSING PRINT WITH SOME HAVING SO PRINT ABOVE THE 2ML MARKING, SOME HAVING INTERMITTENT SECTIONS MISSING THROUGHOUT THE SCALE AND SOME HAVING MINIMAL GRAD LINES WITH ALMOST NO SCALE PRESENT. THE SEVENTY-NINE SYRINGES WITH POOR PRINT WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT WAS LIKELY DUE TO AN INK FLOW ISSUE THAT PREVENTED THE PROPER AMOUNT OF INK FROM BEING APPLIED. MISSING PRINT WAS FOUND DURING THE MANUFACTURE OF THIS BATCH AND A REQUALIFICATION WAS PERFORMED. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 1041510 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 84 BD LUER-LOK¿ DISPOSABLE SYRINGES WITH THE BD LUER-LOK¿ TIP WERE FOUND WITH ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3ML SYRINGES FOUND WITH ML MARKINGS RUBBED OUT THROUGHOUT LENGTH OF SYRINGE DESPITE EXPIRY NOT BEING UNTIL 2026. 84 EACH".

    Additional Manufacturer Narrative · 1

    AGE: UNKNOWN. THE PATIENT¿S DATE OF BIRTH WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. 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 84 BD LUER-LOK¿ DISPOSABLE SYRINGES WITH THE BD LUER-LOK¿ TIP WERE FOUND WITH ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3ML SYRINGES FOUND WITH ML MARKINGS RUBBED OUT THROUGHOUT LENGTH OF SYRINGE DESPITE EXPIRY NOT BEING UNTIL 2026. 84 EACH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744173 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 1041510 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA