BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 10612853 · Received October 1, 2020

    Report

    Report Number
    3003152976-2020-00421
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    August 14, 2020
    Report Date
    October 27, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903006138
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003264, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2003264 WERE USED FOR ADDITIONAL EVALUATION. NO DAMAGE OR DEFECTS WAS OBSERVED ON ANY OF THE SYRINGE TIPS. TIP AND THREAD VERIFICATION TESTS ARE PERFORMED WITHIN THE MANUFACTURING ENVIRONMENT ACCORDING TO PROCEDURE. TESTING WAS PERFORMED ON THE TEN RETAINED SAMPLES AND FOUND ALL PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE LUER TIP BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN ATTACHED TO EXTENSION OF PIVC TIP OF SYRINGE SNAPPED RESULTING IN MEDICATION NOT BEING ABLE TO BE ADMINISTERED, PIVC BEING DAMAGED AND THEREFORE NEED REMOVING AND CHILD HAVING TO UNDERGO FURTHER PROCEDURES DUE TO FAULTY EQUIPMENT. NO INJURY. PEDIATRIC PATIENT REQUIRED NEW CANNULA INSERTION AS CANNULA DAMAGED"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE LUER TIP BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN ATTACHED TO EXTENSION OF PIVC TIP OF SYRINGE SNAPPED RESULTING IN MEDICATION NOT BEING ABLE TO BE ADMINISTERED, PIVC BEING DAMAGED AND THEREFORE NEED REMOVING AND CHILD HAVING TO UNDERGO FURTHER PROCEDURES DUE TO FAULTY EQUIPMENT. NO INJURY. PEDIATRIC PATIENT REQUIRED NEW CANNULA INSERTION AS CANNULA DAMAGED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075648 BD PLASTIPAK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300613 2003264 30382903006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other