BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ 13MM VIAL ACCESS DEVICE

    MDR report key: 15928894 · Received December 6, 2022

    Report

    Report Number
    9616066-2022-01879
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 15, 2022
    Report Date
    January 26, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    27613203013851
    PMA / PMN Number
    K970485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 27-DEC-2022. H6: INVESTIGATION SUMMARY ONE SAMPLE WAS SUBMITTED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF PACKAGING ISSUE-PRODUCT PACKAGING WAS VERIFIED BY VISUAL INSPECTION AND EVALUATION. THE SAMPLE SUBMITTED WERE SUBJECTED TO VISUAL INSPECTION UNDER MAGNIFICATION. THE SAMPLE SHOWED SIGNS OF DAMAGE TO THE CLEAR PLASTIC PACKAGING. THE DAMAGE SEEN WERE SMALL HOLES IN THE PACKAGING THAT VARIED IN SHAPE AND SIZES. FURTHER EXAMINATION OF THE ISSUE IN RELATION TO THE PRODUCT SHOWED THAT THE DAMAGE IN THE PACKAGING WAS ALWAYS ON THE SIDE OF THE PACKAGING WHERE THE LARGE OPENING SIDE OF THE PRODUCT WOULD BE LOCATED. ADDITIONAL EVALUATION WAS CONDUCTED IN ORDER TO DETERMINE IF THE PLASTIC PACKAGING COULD BE PUNCTURED BY THE INTERNAL SPIKE OF THE PRODUCT. ALTHOUGH THE SPIKE IS SHARP ENOUGH TO PUNCTURE THE PLASTIC PACKAGING, IT DID NOT SEEM FEASIBLE THAT THE SPIKE PUNCTURED THE PLASTIC PACKAGING BECAUSE IN ORDER FOR THE PLASTIC PACKAGING TO BE DAMAGED BY THE SPIKE, IT WOULD HAVE TO FORCEFULLY PUSHED INTO THE SPIKE, STRETCHING THE PLASTIC PACKAGING MORE THAN IT WOULD BE STRETCHED IN A NORMAL USE SITUATION. FURTHER INVESTIGATION INTO THE TYPES OF HOLES SEEN, SHOWED THAT SOME OF THE HOLES LOOKED TO BE LONGER IN LENGTH AND REPRESENTED MORE LIKE TEARS IN THE PACKAGING RATHER THAN HOLES. WITH THIS IN MIND, A TEST WAS DONE TO SEE IF STACKING THE PRODUCT IN THE PACKAGING AND PRESSING DOWN ON THE STACK, WOULD CAUSE A TEAR IN THE PLASTIC PACKAGING. THE TEST WAS SUCCESSFUL, AND A TEAR WAS CREATED IN THE PACKAGING THAT WAS SIMILAR TO THE TEARS SEEN IN THE SAMPLE EXAMINED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2203E LOT NUMBER 22075476 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. BASED ON THE FINDINGS OF THE INVESTIGATION, THE PROBABLE ROOT CAUSE OF THE ISSUE LIES IN THE PACKAGING OF THE PRODUCT. AN INVESTIGATION WAS CONDUCTED AT THE MANUFACTURING AND PACKAGING FACILITIES AND IT WAS DETERMINED THAT THE SAMPLES CORRESPONDING TO THE COMPLAINT REPORTED BY THE CUSTOMER, WERE SEALED WITHOUT USING SPACERS OR USING THE ORIENTATION FIXTURE AND THEREFORE THERE IS A RELATIONSHIP BETWEEN THE DAMAGE REPORTED BY THE CUSTOMER AND THE FORMING PROCESS UNDER CONDITIONS THAT CAUSE THE FILM TO BECOME THINNER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ 13MM VIAL ACCESS DEVICE HAD A HOLE/PUNCTURE IN THE OVERWRAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR ANALYTICAL TEAM HAD AN OBSERVATION OF THE PACKAGING OF THE VIAL ADAPTER BEFORE DESIGN VERIFICATION TESTING AND WANTED TO MEET WITH BD TO DISCUSS IF THIS OBSERVATION HAS BEEN SEEN BEFORE. AT A HIGH LEVEL, THE PACKAGING HAS A HOLE/ PUNCTURE IN THE OVERWRAP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ 13MM VIAL ACCESS DEVICE HAD A HOLE/PUNCTURE IN THE OVERWRAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR ANALYTICAL TEAM HAD AN OBSERVATION OF THE PACKAGING OF THE VIAL ADAPTER BEFORE DESIGN VERIFICATION TESTING AND WANTED TO MEET WITH BD TO DISCUSS IF THIS OBSERVATION HAS BEEN SEEN BEFORE. AT A HIGH LEVEL, THE PACKAGING HAS A HOLE/ PUNCTURE IN THE OVERWRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470087 BD SMARTSITE¿ 13MM VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2203E 22075476 27613203013851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown