BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM

    MDR report key: 13419407 · Received February 1, 2022

    Report

    Report Number
    2243072-2022-00126
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2022-01-24. INVESTIGATION SUMMARY ONE MV0420-0006 SAMPLE WAS RECEIVED IN OPENED PACKAGING FROM LOT 202044; THE SAMPLE WAS RECEIVED CONNECTED TO A PACLITAXEL VIAL CONTAINING RESIDUAL MEDICATION. A VISUAL INSPECTION OF THE PRODUCT CONFIRMED THE CUSTOMER'S EXPERIENCE, AS THE SMARTSITE COMPONENT WAS RECEIVED SEPARATED FROM THE VIAL ACCESS DEVICE. THERE APPEARED TO BE RESIDUAL SOLVENT AROUND THE VAD WHERE THE SMARTSITE HAD BEEN DETACHED. A CLOSER INSPECTION OF THE SMARTSITE IDENTIFIED THAT THE BODY OF THE SMARTSITE WAS DISCOLOURED SUGGESTING THAT IT HAD BEEN SUBJECTED TO A SIGNIFICANT AMOUNT OF ALCOHOL. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED SEPARATION COULD NOT BE DETERMINED, HOWEVER IT IS POSSIBLE THAT IT OCCURRED AS A RESULT OF AN INCONSISTENT OR INSUFFICIENT APPLICATION OF GLUE, COUPLED WITH THE TWISTING FORCE DURING ENGAGEMENT OR DISENGAGEMENT OF THE SMARTSITE. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202044 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THE REPORTED FEEDBACK DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MV0420-0006 SET IN THE PAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VVA 20MM HAD THE LUER LOCK CONNECTOR SNAP OFF THE TOP AFTER ATTACHMENT TO A VIAL. THIS MEANT THAT THE DRUG COULD NOT BE EXTRACTED FROM THE VIAL SAFELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VVA 20MM HAD THE LUER LOCK CONNECTOR SNAP OFF THE TOP AFTER ATTACHMENT TO A VIAL. THIS MEANT THAT THE DRUG COULD NOT BE EXTRACTED FROM THE VIAL SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975529 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM SET, IV FLUID TRANSFER LHI BECTON DICKINSON 202044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown