BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 10588471 · Received September 25, 2020

    Report

    Report Number
    1213809-2020-00659
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 7, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND 126 3ML SYRINGES IN FULLY SEALED BLISTER PACKS WERE RECEIVED AND EVALUATED. 123 OF THE SYRINGES WERE COMPLETELY BLANK WITH NO VISIBLE PRINT AND THREE OF THE SYRINGES HAD A SINGLE INK RING NEAR THE MIDDLE OF THE BARREL WITH NO OTHER PRINT PRESENT. ALL THE SYRINGES WERE REJECTABLE PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE EQUIPMENT FAILURE. THERE WAS LIKELY AN INK PUMP FAILURE THAT QUICKLY STOPPED THE INK FLOW, PREVENTING INK FROM BEING APPLIED TO THE BARRELS. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH A REQUALIFICATION FOR MISSING PRINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 200 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP HAD NO SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657. BATCH NO. 0150246. IT WAS REPORTED THAT MULTIPLE SYRINGES WERE FOUND WITH NO SCALE MARKINGS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE: 1675, FDA PATIENT PROBLEM CODE: 2645.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 200 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP HAD NO SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657 BATCH NO. 0150246. IT WAS REPORTED THAT MULTIPLE SYRINGES WERE FOUND WITH NO SCALE MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055363 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0150246 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other