BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50 ML BD PLASTIPAK LUER-SLIP SYRINGE

    MDR report key: 10939118 · Received December 3, 2020

    Report

    Report Number
    3003152976-2020-00542
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 21, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008667
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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: 11/25/2020 H.6. INVESTIGATION: FIVE SEALED SAMPLES OF LOT 2003206 FOR PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, THE MARKING FOR 0ML IS NOT COMPLETELY PRINTED ON THE BARREL, SOME MARKINGS ARE OBSERVED TO BE LIGHTER, HOWEVER, THE SCALE AND MARKINGS ARE LEGIBLE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2003206, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THIS DEFECT CAN OCCUR DUE TO A FAILURE IN THE PATTERS OR FLAMING SYSTEM USED TO TRANSFER THE INK ONTO THE BARREL.SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 50 ML BD PLASTIPAK¿ LUER-SLIP SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMUDGING OF THE LINES AND WORDINGS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ADDR 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 60 50 ML BD PLASTIPAK¿ LUER-SLIP SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMUDGING OF THE LINES AND WORDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404494 50 ML BD PLASTIPAK LUER-SLIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003206 00382903008667

    Patients

    Seq Age Sex Outcome Treatment
    1