BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTERLINK¿ BLUNT PLASTIC CANNULA

    MDR report key: 6952724 · Received October 16, 2017

    Report

    Report Number
    1213809-2017-00197
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 26, 2017
    Report Date
    March 1, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K974363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: DHR WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. NO PHOTOS OR SAMPLES WERE AVAILABLE FOR THE DEVICE EVALUATION. SEE NOTES BELOW. SAMPLE EVALUATION: THREE LOOSE 10ML SYRINGES WITH SHIELDED NEEDLES ATTACHED WERE RECEIVED BY BD (B)(4) FROM A REPORTED MATERIAL #303345 AND UNKNOWN BATCH #. ONE PACKAGED BD PLASTIC CANNULA MATERIAL #303345 WAS ALSO INCLUDED IN THE SAMPLE BAG. THE 10 ML SYRINGE HAS THE SCALE PRINTED ON A STICKER THAT IS ATTACHED TO THE BARREL. THE BARRELS ARE FROM MOLD ¿N-77¿ AND THEREFORE THE MATERIAL WAS NOT MANUFACTURED AT BD (B)(4). THIS IS NOT A (B)(4) PRODUCT. THE SAMPLE WAS FORWARDED TO ANOTHER BD LOCATION. IT WAS MISPLACED AND AN EVALUATION WAS NOT DONE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A BD INTERLINK¿ BLUNT PLASTIC CANNULA WAS FOUND LEAKING CONTRAST NEAR THE HUB. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730425 BD INTERLINK¿ BLUNT PLASTIC CANNULA BLUNT PLASTIC CANNULA FMI BECTON DICKINSON MEDICAL SYSTEMS 6118626

    Patients

    Seq Age Sex Outcome Treatment
    1 Other