BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 9157014 · Received October 4, 2019

    Report

    Report Number
    2243072-2019-02208
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 19, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE BOX WAS RECEIVED, CONTAINING 40 SEALED PACKAGED 3ML SYRINGES, CONFIRMED TO BE FROM BATCH #9171885 (P/N 309657). THE SAMPLES WERE VISUALLY EVALUATED. ALL SAMPLES WERE CONFIRMED TO HAVE MISSING PRINT CONDITION OF THE SCALE MARKINGS. THE AMOUNT OF PRINT MISSING VARIED BETWEEN THE INDIVIDUAL SAMPLES. SOME SAMPLES HAD ONLY THE BD LOGO AND MARKINGS, INCLUDING GRAD LINES, AROUND 3ML MISSING, WHILE SOME SAMPLES HAD MOST OF THE SCALE BETWEEN BD LOGO AND 1ML MISSING. THERE WAS A CLEAR PROGRESSION OF WORSENING MISSING. PRINT OBSERVED FROM ONE SAMPLE TO NEXT. DURING PRODUCTION OF THE REPORTED BATCHES , AN ISSUE WAS IDENTIFIED AND ADDITIONAL MEASURES WERE TAKEN TO ASSURE RELEASE OF THE PRODUCT. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS DUE TO AN ISSUE WITH INK PUMP DURING THE MARKING PROCESS AND INSUFFICIENT DEFECT CONTAINMENT WHEN THE ISSUE WAS DISCOVERED. CORRECTIONS TOOK PLACE WHEN THE ISSUE WAS FOUND DURING THE MANUFACTURE OF BATCH 9171885 (P/N 309657). IT IS POSSIBLE A LIMITED NUMBER OF DEFECTIVE PRODUCT ESCAPED DETECTION DURING REQUALIFICATION ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS PRIOR TO USE WAS DISCOVERED THAT THERE WERE SCALE MARKING ISSUES WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MARKINGS ON SYRINGES THAT INDICATE THEY ARE 3ML.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA / 510(K)#: K980987 (IF (B)(4)) K151766 (IF (B)(4)). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS PRIOR TO USE WAS DISCOVERED THAT THERE WERE SCALE MARKING ISSUES WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MARKINGS ON SYRINGES THAT INDICATE THEY ARE 3ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953104 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other