BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE 5ML FILL

    MDR report key: 9136117 · Received September 30, 2019

    Report

    Report Number
    1911916-2019-01030
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 6, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    NGT
    UDI-DI
    30382903065456
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. IT SHOWS A CASE BOX LABELED AS 306545- 5ML SALINE PRODUCT- WITH HEPARIN SHELF BOXES. THE LINE THAT PRODUCED THE LOT # 9051627 ONLY PRODUCES SALINE PRODUCTS. THE SHELF BOXES ARE INCORRECT. POSSIBLE ROOT CAUSE IS IN THE PACKAGING AREA DUE TO MIXED MATERIAL. THE HEPARIN SHELF BOXES WERE USED TO PACKAGED SALINE PRODUCT; CASE PACK OPERATORS HAVE BEEN TRAINED TO VERIFY THE PRODUCTION ORDER MATERIAL LIST WITH THE MATERIAL TO BE USED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: ONE PHOTO WAS PROVIDED. IT SHOWS A CASE BOX LABELED AS 306545- 5ML SALINE PRODUCT- WITH HEPARIN SHELF BOXES. THE LINE THAT PRODUCED THE LOT # 9051627 ONLY PRODUCES SALINE PRODUCTS. ROOT CAUSE DESCRIPTION: POSSIBLE ROOT CAUSE IS IN THE PACKAGING AREA DUE TO MIXED MATERIAL. THE HEPARIN SHELF BOXES WERE USED TO PACKAGED SALINE PRODUCT; CASE PACK OPERATORS HAVE BEEN TRAINED TO VERIFY THE PRODUCTION ORDER MATERIAL LIST WITH THE MATERIAL TO BE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LABEL ERROR OCCURRED BEFORE USE WITH A SYRINGE 5ML SALINE 5ML FILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE LABEL ON THE SHIPPING BOX DID NOT MATCH WHAT WAS ON THE PRODUCT BOX RECEIVED. OPENED BOX OF 5 ML SALINE FLUSHES MANUFACTURER REORDER #306545. HEPARIN FLUSHES WERE INSIDE THE BOX. THE BOX WAS SEALED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931524 SYRINGE 5ML SALINE 5ML FILL SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON AND COMPANY 9051627 30382903065456

    Patients

    Seq Age Sex Outcome Treatment
    1 Other