BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 16526967 · Received March 10, 2023

    Report

    Report Number
    3003152976-2023-00055
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 21, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 01-MAR-2023. H6: INVESTIGATION SUMMARY: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE THUMB PRESS WAS OBSERVED TO BE BROKEN, SOME OF THE BROKEN PIECES REMAIN INSIDE THE SEALED BLISTER PACK INDICATING THE DAMAGE LIKELY OCCURRED DURING THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 2201026. 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 GETTING DAMAGED DURING THE PACKAGING PROCESS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ SYRINGE PLUNGER RODS BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF INSERTING SYRINGE INTO SYRINGE DRIVE AND THE PLUNGER BREAKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ SYRINGE PLUNGER RODS BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF INSERTING SYRINGE INTO SYRINGE DRIVE AND THE PLUNGER BREAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448264 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown