BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3-PIECE SYRINGE

    MDR report key: 15112180 · Received July 27, 2022

    Report

    Report Number
    3003152976-2022-00334
    Event Type
    Malfunction
    Date Received
    July 27, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE SAMPLE AND SEVERAL PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A FOREIGN MATTER WAS OBSERVED IN THE PLUNGER. FURTHER EVALUATION IDENTIFIED THE MATTER TO BE GREASE, CONSISTENT WITH WHAT IS USED DURING THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2103040, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THIS DEFECT CAN OCCUR DUE TO GREASE ACCUMULATING IN THE MOLD DURING THE MOLDING PROCESS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND INSIDE EIGHT BD PLASTIPAK¿ 3-PIECE SYRINGE WHILE PREPARING MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING MEDICATION PREPARATION A NURSE DISCOVERED THAT THERE WAS SOMETHING INSIDE THE BD PLASTIPAK SYRINGE. SHE HAD ONLY MANAGED TO PULL THE PLUNGER BACK A LITTLE TO FILL THE SYRINGE WITH AIR WHEN SHE DISCOVERED THIS. THE MATERIAL INSIDE THE SYRINGE LOOKS WHITE AND THREAD LIKE, THE MATERIAL IS ON THE PLUNGER, SLIGHTLY ON THE SIDE OF THE PLUNGER AND AT THE VERY TOP OF THE SYRINGE. THE NURSE FOUND SOME OTHER BD PLASTIPAK WITH THE SAME LOT AT THEIR LOCAL STORAGE, BUT THEY DO NOT SEEM TO HAVE THE SAME MATERIAL ON THEM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND INSIDE EIGHT BD PLASTIPAK¿ 3-PIECE SYRINGE WHILE PREPARING MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING MEDICATION PREPARATION A NURSE DISCOVERED THAT THERE WAS SOMETHING INSIDE THE BD PLASTIPAK SYRINGE. SHE HAD ONLY MANAGED TO PULL THE PLUNGER BACK A LITTLE TO FILL THE SYRINGE WITH AIR WHEN SHE DISCOVERED THIS. THE MATERIAL INSIDE THE SYRINGE LOOKS WHITE AND THREAD LIKE, THE MATERIAL IS ON THE PLUNGER, SLIGHTLY ON THE SIDE OF THE PLUNGER AND AT THE VERY TOP OF THE SYRINGE. THE NURSE FOUND SOME OTHER BD PLASTIPAK WITH THE SAME LOT AT THEIR LOCAL STORAGE, BUT THEY DO NOT SEEM TO HAVE THE SAME MATERIAL ON THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722936 BD PLASTIPAK¿ 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown