BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

    MDR report key: 8090574 · Received November 20, 2018

    Report

    Report Number
    9616657-2018-00063
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 5, 2018
    Report Date
    January 9, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHYSICAL SAMPLES BELONGING TO LOT NUMBER 8143609 WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH VISUAL INSPECTION OF THE SAMPLES, BROWN TAPE/CARDBOARD WAS OBSERVED WITHIN THE PRODUCT PACKAGING, PREVENTING A PROPER SEAL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 8143609 THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THE BROWN PAPER PRESENT WITHIN THE SAMPLE ORIGINATES FROM THE SUPPLIER LABEL ROLL CORE. WHEN THE LAST BARREL LABEL IS REMOVED FROM THE ROLL, THE TAPE OF THE ROLL MAY BECOME DETACHED FROM THE ROLL AND THEN ATTACH ITSELF TO THE PRODUCT. THE LABEL ROLL IS MANUFACTURED BY A SUPPLIER LOCATION. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SUBMITTED TO THE SUPPLIER LOCATION FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH STERILE BREACH WITH A SEALING ISSUE.

    Additional Manufacturer Narrative · 1

    (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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH STERILE BREACH WITH A SEALING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931977 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE SYRINGE FMF BECTON, DICKINSON AND CO. 8143609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other