BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE

    MDR report key: 10279770 · Received July 15, 2020

    Report

    Report Number
    3003152976-2020-00310
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE SAMPLES AND PHOTO, THE BARREL THREAD IS OBSERVED TO BE PARTIALLY BROKEN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1912006 AND 1912004, 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. THE AREAS WHERE PRODUCT MOVES WITHIN THE MANUFACTURING EQUIPMENT IS PROTECTED TO AVOID ANY DAMAGE TO THE PRODUCT. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THE DAMAGE OCCURRED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE CHIPPED BEFORE USE. LOT#'S 1912006 AND 1912004 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, EACH WITH 1 OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "10ML SYRINGE 1912006 1 LUERLOCK OF THE SYRINGE HAS CHIPPED - CONTAINS TAUROLOCK 10ML SYRINGE 1912004 1 LUERLOCK OF THE SYRINGE HAS CHIPPED (PATIENT NOT INVOLVED)".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1912006. DEVICE MANUFACTURE DATE: 2019-12-10. MEDICAL DEVICE LOT #: 1912004. DEVICE MANUFACTURE DATE: 2019-12-04. 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 THE TIP OF THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE CHIPPED BEFORE USE. LOT#'S 1912006 AND 1912004 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, EACH WITH 1 OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "10 ML SYRINGE 1912006 1 LUERLOCK OF THE SYRINGE HAS CHIPPED, CONTAINS TAUROLOCK 10 ML SYRINGE 1912004 1 LUERLOCK OF THE SYRINGE HAS CHIPPED (PATIENT NOT INVOLVED)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739856 BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other