BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ POSIFLUSH

    MDR report key: 8280053 · Received January 25, 2019

    Report

    Report Number
    9616657-2019-00102
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 10, 2019
    Report Date
    January 29, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BATCH NO. 7110587 - THE NON-CONFORMANCE'S WERE REVIEWED FOR THIS BATCH AND THERE WAS A RECORD OF NON-CONFORMANCE ASSOCIATED WITH THIS BATCH FOR THIS DEFECT. THE SAMPLES RECEIVED AS PART OF THIS COMPLAINT CONFIRMS PLUNGER MOVEMENT DIFFICULTY. THE NON-CONFORMANCE'S WERE REVIEWED FOR THIS BATCH, AND THERE WAS A RECORD OF NON-CONFORMANCE ASSOCIATED WITH THIS BATCH FOR THIS DEFECT. THERE WAS AN INTERMITTENT ISSUE WITH THE SILICON HOSING WHICH WAS INVESTIGATED AND RESOLVED AT THAT TIME. ALL PRODUCT ASSOCIATED WITH THE DEFECT WAS HELD FOR INSPECTION, AND ANY AFFECTED MATERIAL WAS SCRAPPED. ALTHOUGH, IT IS POSSIBLE THAT THE SAMPLES RETURNED AS PART OF THIS COMPLAINT MAY HAVE BEEN MANUFACTURED PRIOR TO DETECTION OR THERE MAY HAVE BEEN A LIMITED OCCURRENCE OF PRODUCT WHICH WAS PRODUCED OUTSIDE THE CONTAINED MATERIAL. THE HOSING AT THE SILICON STATION IN FILL ROOM WAS INVESTIGATED AND ISSUE RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD¿ POSIFLUSH DID NOT PUSH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 THAT TWO BD¿ POSIFLUSH DID NOT PUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69830 BD¿ POSIFLUSH VASCULAR CATHETER FLUSH SYRINGE FOZ BECTON, DICKINSON AND CO. 7110587 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other