BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER 20G X 1.88IN

    MDR report key: 7014800 · Received November 9, 2017

    Report

    Report Number
    9610048-2017-00060
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 3, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FOZ
    UDI-DI
    30382903811374
    PMA / PMN Number
    K950301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    NO SAMPLES OR PHOTOS WERE RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. THE FINAL ASSEMBLY BATCHES: 6146449SH, 6146457SH USED IN THE CLAIMED FINAL PRODUCT BATCHES: 6193418 OF ANGIOCATH 20G X 1.88 WW WERE CHECKED AND TESTED FOR PRESENCE OF "FOREIGN/NO-FOREIGN MATTER" AND THERE WERE NO RECORDS OF THIS DEFECT. THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS OF FOREIGN MATTER, FOR THE LOTS INVOLVED IN THIS COMPLAINT, ACCORDING TO THE DHR OF THE LOT ABOVE. NOT CONFIRMED: BD WAS UNABLE TO CONFIRM THE INCIDENT IN QUESTION. AS NO PHOTOS OR SAMPLES RETURNED FROM THE CLIENT WERE RECEIVED FOR ANALYSIS, THE PRESENCE OF FOREIGN MATTER IN THE CATHETER COULD NOT BE CONFIRMED. BASED ON A SEVERITY ASSESSMENT AND OCCURRENCE IT WAS DETERMINED THAT NO CAPA IS REQUIRED AT THIS TIME. THE COMPLAINT WAS ADDED TO THE COMPLAINT DATABASE FOR TREND ANALYSIS, WHICH IS REGULARLY MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND DEPOSITED ON THE SURFACE OF SEVERAL BD ANGIOCATH¿ IV CATHETER 20G X 1.88IN PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794937 BD ANGIOCATH¿ IV CATHETER 20G X 1.88IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON AND CO. 6193418 30382903811374

    Patients

    Seq Age Sex Outcome Treatment
    1 Other