BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOW MICRO 90 SPIKE ANTI-SIPHON VALVE

    MDR report key: 11457093 · Received March 10, 2021

    Report

    Report Number
    2243072-2021-00727
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT#: TEST081-17/273. H.6. INVESTIGATION: A EPI00012-NRF PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT TEST081-17/273. AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE PACKAGING OF THE EPI00012-NRF PRODUCT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, CAESAREA MEDICAL ELECTRONICS LTD. FOR INVESTIGATION. IT WAS CONFIRMED THAT THE INSTRUCTIONS ON THE PACKAGING OF THE EPI00012-NRF AND EPI00011-NRF PRODUCT WERE FOUND TO BE THE SAME. IT WAS ALSO CONFIRMED THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE EPI00012-NRF PRODUCT STATES "DEHP OR NATURAL RUBBER LATEX ARE NOT PART OF THE MATERIAL FORMULATION". IN THIS INSTANCE IT WAS NOT CLEAR FROM THE FEEDBACK WHETHER THE CUSTOMER DID NOT RECEIVE THE IFU WITH THIS PRODUCT, OR WHETHER THERE WAS A MISUNDERSTANDING OF WHERE THE LABELLING WAS FOR THE PRODUCT. A REVIEW OF THE PRODUCTION RECORDS FOR LOT TEST081-17/273 CONFIRMED THAT THIS LOT WAS NOT MANUFACTURED FOR HUMAN USE, AND THE PRODUCT WAS LABELLED WITH A STATEMENT SUGGESTING 'NOT STERILIZED. NOT FOR HUMAN USE'. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE YELLOW MICRO 90 SPIKE ANTI-SIPHON VALVE SAMPLE DID NOT HAVE "DEHP" ON THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED SAMPLES TODAY BUT ON SAMPLE (B)(6) IT DOES NOT SAY DEHP BUT IT DOES ON SAMPLE (B)(6) SHOULD BE THE SAME ON BOTH"

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT # [TEST081-17/273] WAS NOT FOUND FOR THE REPORTED CATALOG # [EPI00012-NRF]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE YELLOW MICRO 90 SPIKE ANTI-SIPHON VALVE SAMPLE DID NOT HAVE "DEHP" ON THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED SAMPLES TODAY BUT ON SAMPLE (B)(6) IT DOES NOT SAY DEHP BUT IT DOES ON SAMPLE (B)(6) SHOULD BE THE SAME ON BOTH"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346798 YELLOW MICRO 90 SPIKE ANTI-SIPHON VALVE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON TEST081-17/273

    Patients

    Seq Age Sex Outcome Treatment
    1