BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ 3-PIECE SYRINGE

    MDR report key: 15070669 · Received July 20, 2022

    Report

    Report Number
    3003152976-2022-00325
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 20, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 19-JUL-2022. H6: INVESTIGATION SUMMARY MULTIPLE SAMPLES AND PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE THUMB PRESS WAS OBSERVED TO BE BROKEN. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 2110136. THE AREAS WHERE PIECES MOVE WITHIN THE MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE 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, IT WAS DETERMINED THE DAMAGE WAS LIKELY CAUSED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ 3-PIECE SYRINGE PLUNGER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER OF THE PLASTIPAK 50 ML SYRINGES IS FREQUENTLY BROKEN LATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ 3-PIECE SYRINGE PLUNGER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER OF THE PLASTIPAK 50 ML SYRINGES IS FREQUENTLY BROKEN LATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719644 BD PLASTIPAK ¿ 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110136

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown