BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT

    MDR report key: 7768632 · Received August 9, 2018

    Report

    Report Number
    1710034-2018-00522
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 20, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED A TOTAL OF 3 UNITS OF WHICH 2 WERE WITHIN SEALED PACKAGES AND 1 WAS ON AN OPEN PACKAGE. THE UNUSED UNITS WERE INTACT AND ALL COMPONENTS WERE PRESENT. THE USED UNIT CONSISTED OF A CATHETER-ADAPTER ASSEMBLY WITH AN EXTENSION TUBING WITH A Y ADAPTER AND 2 Q-SYTE ASSEMBLIES ATTACHED TO IT AND A PIECE OF TOP WEB (PACKAGING) FROM LOT NUMBER 8031857, THE REMAINDER OF THE UNIT (NEEDLE-GRIP ASSEMBLY) WAS NOT RETURNED FOR EVALUATION. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE WITH LOT # 8031857 REGARDING ITEM #383536. DHR REVIEW SHOWS A TOTAL OF (B)(4) WERE MANUFACTURED ON NEXIVA LINE 1 STARTING ON 2FEB18 THROUGH 10FEB18. FOUND 4 NON-RELATED QN¿S WHERE DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. ALL OTHER CHALLENGES, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. VISUAL/MICROSCOPIC EVALUATION: UNUSED UNITS: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE UNITS. THE WATER/AIR LEAK TEST WAS PERFORMED (CATHETER ADAPTER-EXTENSION SET) PER QCGE-011. NO LEAKAGE WAS OBSERVE ON ANY OF THE COMPONENTS USED UNIT: OBSERVED THE EXTENSION TUBING WAS NOT CORRECTLY INSERTED INTO THE Y ADAPTER LEAVING A SMALL GAP BETWEEN THE TUBING AND THE ADAPTER¿S WALL. THE WATER/AIR LEAK TEST WAS PERFORMED AND LEAKAGE WAS OBSERVED ON THE CONNECTION OF THE EXT. TUBING AND THE Y ADAPTER. ROOT CAUSE IS DETERMINED TO BE RELATED TO MANUFACTURING. THE EXTENSION TUBE WAS NOT PROPERLY INSERTED INTO THE CATHETER ASSEMBLY PORT DURING THE MANUFACTURING BONDING OPERATION. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. THE ANALYSIS OF PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS DISCLOSED THAT DUE TO LOW OCCURRENCE AND LIMITED SEVERITY, CURRENT RISK IS ACCEPTABLE. THIS INCIDENT DOES NOT EXCEED WHAT IS CONSIDERED ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607347 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8031857 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other