BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPACK SYRINGE

    MDR report key: 12788600 · Received November 10, 2021

    Report

    Report Number
    3003152976-2021-00745
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 11, 2021
    Report Date
    December 2, 2021
    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

    H6: INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. TEN RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, UPON VISUAL INSPECTION OF THE SAMPLES NO DAMAGE CAN BE OBSERVED IN THE TIP OF THE SYRINGES. NO MOLDING DEFECT CAN BE OBSERVED THAT COULD LEAD TO THE DEFECT EXPERIENCED BY CUSTOMER. CATHETER TIPS (CT TIPS) INTENDED USE IS TO ADMINISTER LIQUIDS INTO A CATHETER OR FEEDING TUBES. OUT OF THE SCOPE OF THIS TYPE OF THESE TIPS IS THE USE WITH NEEDLES. THIS PRODUCT DOES NOT HAVE A LUER TIP CONNECTION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2103011, 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 PROCEDURE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED 4 BD PLASTIPACK SYRINGES HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PUSHING THE SYRINGE DOWN, THE MEDICATION STARTED TO FLOW OVER THE TOP OF THE NEEDLE WHERE IT SCREWS INTO THE SYRINGE. 3 OTHER NEEDLES WERE TRIED FROM THE SAME BOX AND THE SAME THING HAPPENED."

    Description of Event or Problem · 0

    IT WAS REPORTED 4 BD PLASTIPACK SYRINGES HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PUSHING THE SYRINGE DOWN, THE MEDICATION STARTED TO FLOW OVER THE TOP OF THE NEEDLE WHERE IT SCREWS INTO THE SYRINGE. 3 OTHER NEEDLES WERE TRIED FROM THE SAME BOX AND THE SAME THING HAPPENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688834 BD PLASTIPACK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown