BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

    MDR report key: 8091045 · Received November 20, 2018

    Report

    Report Number
    1710034-2018-00823
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 30, 2018
    Report Date
    February 14, 2019
    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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- 8150750 THE LOT NUMBER WAS BUILT / PACKAGE ON NFA LINE 1 FROM 30MAY2018 THRU 08JUNE2018 REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED QN (B)(4) (EXTENSION TUBE BOND OOS) WAS INITIATED DURING THE BUILD OF THIS LOT THAT COULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. REVIEW DISCLOSED NON-RELATED SEVEN QN¿S WERE INITIATED (SIX IN-PROCESS AND ONE FINISH GOODS) DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. 8121733 THE LOT WAS BUILT ON NFA LINE 1 FROM 3MAY2018 THROUGH 7MAY2018 FOR THE AMOUNT OF 268,810EA QN (B)(4) FOR ¿EXT TUBE ADHESIVE OOS¿ COULD BE POTENTIALLY RELATED TO THIS INCIDENT. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS FOR THE QUALITY NOTIFICATION ARE CURRENTLY IN PROCESS. TD 2018-23 (ADHESIVE DEEP CLEANING) AND TD 2018-29 (ADHESIVE VALVES PURGE) WERE IN PLACED DURING THE PRODUCTION OF THE LOT # RELATED TO THIS INVESTIGATION. ALL OTHER CHALLENGE, SET UP AND CORRECTIVE ACTIONS WERE PERFORMED ACCORDING TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. RECEIVED A TOTAL OF 3 UNITS AS FOLLOWS ALONG WITH 2 PIECES OF TOP WEB PACKAGING: UNITS 1 AND 2: RECEIVED 2 CATHETER ADAPTER EXTENSION SETS. THE NEEDLE ASSEMBLIES WERE NOT RETURNED. UNIT 3: RECEIVED A FULL 20GA NEXIVA ASSEMBLY WITH AN ADDITIONAL Q-SYTE UNIT. UNITS (B)(4). TRACES OF PATIENT RESIDUE WAS OBSERVED THROUGHOUT THE COMPONENTS OF THE UNITS RECEIVED THE EXTENSION TUBING WAS NOT INSERTED (ATTACHED) TO THE PORT OF THE WINGED ADAPTERS. NO TRACE OF ADHESIVE WAS OBSERVED ON THE TUBING. TRACES OF ADHESIVE RESIDUE WERE PRESENT ON THE OUTER RIM OF THE WING ADAPTER PORTS (B)(4) NO PHYSICAL MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE UNIT. THE EXTENSION TUBINGS WERE PROPERLY INSERTED INTO THE PORTS OF THE WINGED ADAPTER CONCLUSION(S): THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON (B)(6) 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 (B)(6) 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 DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT THE TUBING DISCONNECTED AT THE HUB WHERE IT MEETS THE SECUREMENT PLATFORM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8150750, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-05-30. MEDICAL DEVICE LOT #: 8121733 , MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-05-01 . 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 DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT THE TUBING DISCONNECTED AT THE HUB WHERE IT MEETS THE SECUREMENT PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929881 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other