BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 14853933 · Received June 29, 2022

    Report

    Report Number
    3003152976-2022-00298
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    May 24, 2022
    Report Date
    July 15, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER TELEPHONE NUMBER (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110020, 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. TEN RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPERS WERE VERIFIED TO BE PROPERLY ASSEMBLED ON TO THE PLUNGER ROD, AND NO LEAK WAS IDENTIFIED. BASED ON OUR INVESTIGATION, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PLASTIPAK¿ SYRINGE 2 DIFFERENT SYRINGES SOLUTION LEAKED FROM BARREL PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOLUTION LEAKING THROUGH FROM BARREL PAST THE PLUNGER ON 2 DIFFERENT SYRINGES" THE CUSTOMER REPLIED THERE WAS NO VISIBLE DAMAGE TO THE BARREL. THE SAMPLE IS ALSO NOT AVAILABLE TO BE SENT IN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PLASTIPAK¿ SYRINGE 2 DIFFERENT SYRINGES SOLUTION LEAKED FROM BARREL PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOLUTION LEAKING THROUGH FROM BARREL PAST THE PLUNGER ON 2 DIFFERENT SYRINGES." THE CUSTOMER REPLIED THERE WAS NO VISIBLE DAMAGE TO THE BARREL. THE SAMPLE IS ALSO NOT AVAILABLE TO BE SENT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366146 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown