BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN

    MDR report key: 9672493 · Received February 5, 2020

    Report

    Report Number
    1710034-2020-00057
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    November 3, 2019
    Report Date
    February 27, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE FOR EVALUATION. BD RECEIVED ONE RETRACTED UNIT AND THE TOP WEBBING OF THE PACKAGING WHICH INDICATED THE ITEM NUMBER OF 383536 AND LOT NUMBER 9233234. THROUGH THE VISUAL INSPECTION THE UNIT REVEALED A CUT/SLIT IN THE TUBING NEAR THE ADAPTER. A WATER AIR LEAK TEST WAS PERFORMED WHERE LEAKAGE WAS OBSERVED ON THE EXTENSION TUBING. FURTHER MICROSCOPIC EVALUATION OF THE LEAKAGE REVEALED DAMAGE TO THE EXTENSION TUBING APPROXIMATELY AN INCH AWAY FROM THE ADAPTER. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A DAMAGED PALLET. THE TUBING WAS PINCHED BETWEEN THE GRIPPER FINGERS AND THE PALLET. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383536 BATCH NO. 9233234 CALLED CUSTOMER TO VERIFY SITUATION AS OUR MANUFACTURING FACILITY RECEIVED WRONG PRODUCT. CUSTOMER STATED THAT THERE WAS AN ADDITIONAL MEDWATCH REPORT FOR MATERIAL 383536 THAT ISSUE TOOK PLACE ON NOVEMBER 3RD. I ASKED IF SHE COULD SEND US THIS FORM SO WE CAN LOG THE COMPLAINT , DUE TO NOT LOCATING A COMPLAINT IN THE SYSTEM FOR THIS PRODUCT FROM THEIR FACILITY.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # (B)(4). 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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383536 BATCH NO. 9233234. CALLED CUSTOMER TO VERIFY SITUATION AS OUR MANUFACTURING FACILITY RECEIVED WRONG PRODUCT. CUSTOMER STATED THAT THERE WAS AN ADDITIONAL MEDWATCH REPORT FOR MATERIAL 383536 THAT ISSUE TOOK PLACE ON NOVEMBER 3RD. I ASKED IF SHE COULD SEND US THIS FORM SO WE CAN LOG THE COMPLAINT , DUE TO NOT LOCATING A COMPLAINT IN THE SYSTEM FOR THIS PRODUCT FROM THEIR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137972 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 9233234 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other