BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 10282829 · Received July 16, 2020

    Report

    Report Number
    1213809-2020-00463
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    January 24, 2019
    Report Date
    July 22, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR RECORDS INDICATE THAT CUSTOMER COMPLAINTS HAVE BEEN RECEIVED DESCRIBING ISSUES WITH THE PRINTED SCALE ON 3ML LUER-LOK SYRINGES (MATERIAL NO. 309657). PRINTED SCALE MARKINGS ON THE 3ML SYRINGES ARE PRINTED INCORRECTLY. THE SCALE IS SKEWED TO VARYING DEGREES, RESULTING IN MISSING AND/OR PARTIALLY PRINTED SCALE NUMBERS AND SCALE LINES. COMPLAINTS RELATED TO THIS DEFECT ARE CONFINED TO FINAL BATCH #8303571. DEVICE HISTORY RECORD REVIEW FOR BATCH #8303571 WAS REVIEWED. BATCH #8303571 CONSISTS OF 2 MARKING/ASSEMBLY BATCHES: 8287867 AND 8287868 (P/N 8000314). BATCH #8287867 WAS MANUFACTURED 07-NOV-2018 ¿ 09-NOV-2018 (0600). NO ISSUES WERE RECORDED DURING THE MANUFACTURE OF THIS BATCH. BATCH #8287868 WAS MANUFACTURED 09-NOV-2018 (0600) ¿ 11-NOV-2018. MISSING PRINT WAS RECORDED 2 TIMES DURING THE MANUFACTURE OF THIS BATCH. MISSING PRINT WAS FOUND AT ASSEMBLY DURING THE HOURLY CHECK; ADJUSTMENT WAS RECORDED. PRODUCT WAS REQUALIFIED PER AQL: NO DEFECTS WERE FOUND, THEREFORE THE PRODUCT WAS ACCEPTED; ROOT CAUSE OF THE PROBLEM: A COMBINATION OF PERSONNEL, PROCESS, AND EQUIPMENT CAN BE IDENTIFIED AS AN ASSIGNABLE ROOT CAUSE CORRECTIVE AND PREVENTIVE ACTION, CAPA#753644, WERE INITIATED TO FURTHER INVESTIGATE THIS ISSUE. IMMEDIATE ACTIONS WERE TAKEN TO PUT POTENTIALLY AFFECTED PRODUCT ON HOLD. FIELD ACTION NOTICE # MDS-19-1431-FA. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WAS MISSING THE SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO: 8303571. IT WAS REPORTED THAT SYRINGES HAVE SOME OF THE INK MISSING ON THE ML MARKINGS. ISSUE: HAVE SOME OF THE INK MISSING ON THE ML MARKINGS. SOME OF THE SYRINGES HAVE THE 1.5 ML LEVEL MISSING THE ½ MARK WHICH MAKES IT LOOK LIKE IT IS THE 1ML MARKING. IT COULD LEAD TO OVERMEDICATING PATIENTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WAS MISSING THE SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO: 8303571 IT WAS REPORTED THAT SYRINGES HAVE SOME OF THE INK MISSING ON THE ML MARKINGS. ISSUE: HAVE SOME OF THE INK MISSING ON THE ML MARKINGS. SOME OF THE SYRINGES HAVE THE 1.5 ML LEVEL MISSING THE ½ MARK WHICH MAKES IT LOOK LIKE IT IS THE 1ML MARKING. IT COULD LEAD TO OVERMEDICATING PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751234 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 8303571 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other