BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) ANGIOCATH PLUS

    MDR report key: 9078078 · Received September 17, 2019

    Report

    Report Number
    8041187-2019-00734
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PHOTO FOR 382434 LOT 910524 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO WAS NOT CLEAR ENOUGH TO OBSERVE IF THE BLACK DOT WAS INDEED FOREIGN MATTER OR A BLACK MARK ON THE CANNULA. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. A BATCH REVIEW WAS PERFORMED FOR THE LAST 12 MONTHS OF QUALITY NOTIFICATION AND NONE WERE RAISED FOR THE REPORTED NONCONFORMANCE. THIS COMPLAINT WILL BE MONITORED AND TRACKED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) ANGIOCATH PLUS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A BLACK DOT FOREIGN MATERIAL ON THE CATHETER TUBE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) ANGIOCATH PLUS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A BLACK DOT FOREIGN MATERIAL ON THE CATHETER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872682 20G X 1.16IN (1.1 X 30 MM) ANGIOCATH PLUS INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9101524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other