BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VAD-MULTIPACK (25)

    MDR report key: 11159465 · Received January 13, 2021

    Report

    Report Number
    2243072-2021-00087
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 15, 2020
    Report Date
    March 18, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 202018. D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4: DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: ONE MV042025-0006 SAMPLE FROM LOT 202018 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. THE DEVICE WAS RECEIVED ATTACHED TO AN EMPTY 60MG KYPROLIS BOTTLE. A VISUAL INSPECTION IDENTIFIED THAT THE AIR VENT HAD BEEN BROKEN AWAY FROM THE BODY OF THE MV042025-0006; FURTHERMORE IT WAS IDENTIFIED THAT THE SMARTSITE WAS SEPARATED FROM THE VIAL ACCESS DEVICE (VAD), HOWEVER GLUE WAS VISIBLE AT THE AFFECTED JOINT. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. ANALYSIS OF THE RETURNED SAMPLE DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE, THE AIR VENT APPEARED TO HAVE BEEN BROKEN OFF THE COMPONENT SUGGESTING THAT IT HAD BEEN SUBJECTED TO AN EXTERNAL FORCE. AS PART OF THE FEEDBACK THE CUSTOMER INDICATES THAT LEAKAGE WAS OBSERVED BETWEEN THE SMARTSITE AND THE VAD, A DEFINITIVE ROOT CAUSE FOR THE LEAKAGE COULD NOT BE DETERMINED, HOWEVER IT IS POSSIBLE THAT AN INCONSISTENT AMOUNT OF SOLVENT COUPLED WITH THE TWISTING FORCE DURING ENGAGEMENT OR DISENGAGEMENT OF THE SMARTSITE COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202018 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS ISSUE, THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS COMPLAINT IN ORDER TO BE AWARE OF THE REPORTED FAILURE MODE DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE MV042025-0006 PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMARTSITE 20MM VENTED VAD-MULTIPACK (25) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PREPARER ADAPTED A 20MM SPIKE TO A 60MG KYPROLIS BOTTLE. THIS ANTI-CANCER DRUG REQUIRES RECONSTITUTION. DURING THE INJECTION OF THE RECONSTITUTION SOLVENT (WATER PPI), A DROP OF EPPI LEAKED THROUGH A CONNECTION POINT OF THE SPIKE, MORE PRECISELY BETWEEN THE GREEN PART AND THE LUER LOCK OF THE BI-DIRECTIONAL VALVE. AND WHEN THE PREPARER SAMPLED: THE KYPROLIS FLOWED MORE SLOWLY THAN USUAL AND THERE WERE LARGE BUBBLES, WITHOUT ANY PRODUCT LEAKING THROUGH THE SPIKE THIS TIME. CLINICAL CONSEQUENCES OBSERVED: NONE FOR THE PATIENT BECAUSE OF A QUALITY DEFECT FOUND IN THE CHEMOTHERAPY PREPARATION UNIT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 202018. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMARTSITE 20MM VENTED VAD-MULTIPACK (25) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PREPARER ADAPTED A 20MM SPIKE TO A 60MG KYPROLIS BOTTLE. THIS ANTI-CANCER DRUG REQUIRES RECONSTITUTION. DURING THE INJECTION OF THE RECONSTITUTION SOLVENT (WATER PPI), A DROP OF EPPI LEAKED THROUGH A CONNECTION POINT OF THE SPIKE, MORE PRECISELY BETWEEN THE GREEN PART AND THE LUER LOCK OF THE BI-DIRECTIONAL VALVE. AND WHEN THE PREPARER SAMPLED: THE KYPROLIS FLOWED MORE SLOWLY THAN USUAL AND THERE WERE LARGE BUBBLES, WITHOUT ANY PRODUCT LEAKING THROUGH THE SPIKE THIS TIME. CLINICAL CONSEQUENCES OBSERVED: NONE FOR THE PATIENT BECAUSE OF A QUALITY DEFECT FOUND IN THE CHEMOTHERAPY PREPARATION UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58230 SMARTSITE 20MM VENTED VAD-MULTIPACK (25) SET, I.V. FLUID TRANSFER LHI BECTON DICKINSON 202018

    Patients

    Seq Age Sex Outcome Treatment
    1