BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

    MDR report key: 14428026 · Received May 18, 2022

    Report

    Report Number
    2243072-2022-00700
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 30, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A MV0520-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 9248. FEEDBACK PROVIDED BY THE CUSTOMER INDICATES THAT THE LEAKAGE WAS OBSERVED FROM THE CONNECTION BETWEEN THE VIAL AND THE MV0520-0006 DEVICE DURING ATTEMPTED ASPIRATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 9248 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSIDE THE HOOD MAKING, ATTACHED CVA TO VIAL, ATTACHED TEXIUM SYRINGE AND INVERTED VIAL TO WITHDRAW REQUIRED VOLUME, BEGAN PUSHING THE AIR BACK UP INTO THE VIAL AND THEN THE CONTENTS OF THE VIAL STARTED FREELY LEAK OUT FROM BETWEEN THE CVA AND THE VIAL, WAS ABLE TO GET THE VOLUME I REQUIRED (2ML) BUT THEN HAD TO DISCARD THE REST OF THE VIAL (APPROX. 48ML). PREPARATION INVOLVED: ETOPOSIDE (ETOPOPHOS®) 1G VIAL. WAS THERE A SPILL? YES. WHAT WAS THE CAUSE OF THE SPILL? IE; WHERE WAS THE EQUIPMENT LEAKING FROM? WAS LEAKING FROM BETWEEN THE CVA AND THE VIAL, FREELY FLOWING OUT. WAS THERE ANY HARM OR EXPOSURE TO THE OPERATOR? YES, BUT I WAS INSIDE THE HOOD AND THE SMALL SPILL WAS CONTAINED BY MY DAY-LEE TOWEL INSIDE THE HOOD. TECHNICIAN/PHARMACIST INVOLVED: PHARMACIST. WHERE EXACTLY DID THE LEAK OCCUR? (I.E. BETWEEN THE STOPPER AND THE DEVICE, AT THE SMARTSITE, ETC.) WAS LEAKING FROM BETWEEN THE CVA AND THE VIAL, FREELY FLOWING OUT. COULD YOU SEE IF THE SPIKE FULLY PENETRATED THE STOPPER? (COULD THE SPIKE TIP BE SEEN THROUGH THE STOPPER IN THE VIAL) YES, IT WAS CONNECTED CORRECTLY. WAS THE USER/PATIENT EXPOSED TO ANY HAZARDOUS DRUG? YES, BUT USER HAD 2 SETS OF GLOVES AND GARMENTS ON WHICH PROTECTED THEM FROM HARM. IF YES TO ABOVE THEN, WAS THERE A LIFE-THREATENING INJURY INVOLVED? NO. DID IT RESULT IN PERMANENT IMPAIRMENT OF ANY BODY FUNCTION? NO. WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED? NO. CAN THEY PROVIDE AN UPDATE ON THE USER¿S CURRENT CONDITION? USER NOT HARMED OR ANY FURTHER ISSUE SINCE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSIDE THE HOOD MAKING, ATTACHED CVA TO VIAL, ATTACHED TEXIUM SYRINGE AND INVERTED VIAL TO WITHDRAW REQUIRED VOLUME, BEGAN PUSHING THE AIR BACK UP INTO THE VIAL AND THEN THE CONTENTS OF THE VIAL STARTED FREELY LEAK OUT FROM BETWEEN THE CVA AND THE VIAL, WAS ABLE TO GET THE VOLUME I REQUIRED (2ML) BUT THEN HAD TO DISCARD THE REST OF THE VIAL (APPROX. 48ML). PREPARATION INVOLVED: ETOPOSIDE (ETOPOPHOS®) 1G VIAL. WAS THERE A SPILL? - YES. WHAT WAS THE CAUSE OF THE SPILL? IE; WHERE WAS THE EQUIPMENT LEAKING FROM? ¿ WAS LEAKING FROM BETWEEN THE CVA AND THE VIAL, FREELY FLOWING OUT. WAS THERE ANY HARM OR EXPOSURE TO THE OPERATOR? YES, BUT I WAS INSIDE THE HOOD AND THE SMALL SPILL WAS CONTAINED BY MY DAY-LEE TOWEL INSIDE THE HOOD. TECHNICIAN/PHARMACIST INVOLVED: PHARMACIST. -WHERE EXACTLY DID THE LEAK OCCUR? (I.E. BETWEEN THE STOPPER AND THE DEVICE, AT THE SMARTSITE, ETC.) ¿ WAS LEAKING FROM BETWEEN THE CVA AND THE VIAL, FREELY FLOWING OUT. -COULD YOU SEE IF THE SPIKE FULLY PENETRATED THE STOPPER? (COULD THE SPIKE TIP BE SEEN THROUGH THE STOPPER IN THE VIAL) ¿ YES, IT WAS CONNECTED CORRECTLY. -WAS THE USER/PATIENT EXPOSED TO ANY HAZARDOUS DRUG? YES, BUT USER HAD 2 SETS OF GLOVES AND GARMENTS ON WHICH PROTECTED THEM FROM HARM. ¿ IF YES TO ABOVE THEN, ¿ WAS THERE A LIFE-THREATENING INJURY INVOLVED? NO. ¿ DID IT RESULT IN PERMANENT IMPAIRMENT OF ANY BODY FUNCTION? NO. ¿ WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED? NO. ¿ CAN THEY PROVIDE AN UPDATE ON THE USER¿S CURRENT CONDITION? USER NOT HARMED OR ANY FURTHER ISSUE SINCE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802248 BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 9248

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown