BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEXIVA

    MDR report key: 8240839 · Received January 11, 2019

    Report

    Report Number
    1710034-2018-00984
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 20, 2018
    Report Date
    February 13, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AN ADDITIONAL LOT WAS ADDED TO THE COMPLAINT. D.4. MEDICAL DEVICE LOT #: 8225504, D.4. MEDICAL DEVICE EXPIRATION DATE: 08/31/2021, H.4. DEVICE MANUFACTURE DATE: 08/13/22019. H.6. INVESTIGATION SUMMARY: THE DHR REVIEW WAS PERFORMED ON BOTH THE REPORTED LOT, 8263628 AND THE LOT NUMBER , 8225504 OF THE TOP WEB (PACKAGING) RECEIVED. 8263628. THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 24SEP18 THROUGH 3OCT18. 2 POTENTIALLY RELATED TD¿S WERE IN PLACE. 2018-51 : Z8 INCREASED SAMPLING. 2018-52 ¿ DEPTH PROBES CLEAN UP INSTRUCTIONS. ALL OTHER REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS AND ALL PASSED PER SPECIFICATIONS INCLUDING (BUT NOT LIMITED) EXTENSION PULL (IN-PROCESS AND HEIGHTENED PER TD 2018-15) AND VISUAL INSPECTIONS FOR ADHESIVE PRESENCE AND ALL PASSED PER SPECIFICATIONS. 8225504 THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 26AUG2018 THRU 05SEPT2018. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE CONTROL PLANS. QN 200769632 (KINKED TUBING) AND QN 200768793 (MISSING PRINT-PKG) WERE INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED PER QUALITY PLANS. RECEIVED A 20GA NEXIVA CATHETER-ADAPTER EXTENSION SET ALONG WITH A PIECE OF TOP WEB FROM LOT NUMBER 8235504. THE REMAINDER OF THE UNIT (NEEDLE ASSEMBLY) WAS NOT RETURNED FOR EVALUATION. CONCLUSION(S): THE EXTENSION TUBING WAS DISCONNECTED FROM THE PORT OF THE WINGED ADAPTER. TRACES OF ADHESIVE RESIDUE WERE PRESENT ON THE OUTER RIM OF THE WING ADAPTER PORT. THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON 11 SEP 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON 26 SEP 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED. CAPA 684099 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ NEXIVA EXPERIENCED SEPARATION BETWEEN THE BUTTERFLY WINGS DURING USE.

    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 BD¿ NEXIVA EXPERIENCED SEPARATION BETWEEN THE BUTTERFLY WINGS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34357 BD¿ NEXIVA PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8225504 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other