BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD WINGSET

    MDR report key: 11014087 · Received December 15, 2020

    Report

    Report Number
    2243072-2020-02071
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 23, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM YOUR FACILITY FOR EVALUATION. ADDITIONALLY, WE WERE UNABLE TO DETERMINE THE SPECIFIC CATALOG OR LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE UNSPECIFIED BD WINGSET EXPERIENCED BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE SPLATTER EVENT OCCURRED 1 TIME. AN ADDITIONAL UNKNOWN EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT IS REPORTED THAT CUSTOMER "EXPERIENCED BLOOD SPLATTER AND REPORTS WINGSET DOESN'T WORK ON NEWBORN'S. FACEBOOK COMMENT RECEIVED, - "I PREFER THE OLD BUTTERFLY OR VACUTAINER THIS ONE WHEN YOU REMOVE IT SPLASH AN ALSO IT DOESN'T WORK AN NEWBORN'S ." EMAIL RECEIVED HAS TWO NEGATIVE COMMENTS LEFT ON A BD FACEBOOK POST. THIS COMPLAINT (PR 2109988) IS FOR FACEBOOK USER (B)(6). THE SECOND NEGATIVE COMMENT WAS FROM FACEBOOK USER (B)(6) WHICH WAS FILED AND RELATED UNDER (PR 2110125).

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNSPECIFIED BD WINGSET EXPERIENCED BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE SPLATTER EVENT OCCURRED 1 TIME. AN ADDITIONAL UNKNOWN EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT IS REPORTED THAT CUSTOMER "EXPERIENCED BLOOD SPLATTER AND REPORTS WINGSET DOESN'T WORK ON NEWBORN'S. (B)(4) COMMENT RECEIVED, "I PREFER THE OLD BUTTERFLY OR VACUTAINER THIS ONE WHEN YOU REMOVE IT SPLASH AN ALSO IT DOESN'T WORK AN NEWBORN'S." EMAIL RECEIVED HAS TWO NEGATIVE COMMENTS LEFT ON A BD (B)(4)POST. THIS COMPLAINT ((B)(4)) IS FOR (B)(4) USER (B)(6). THE SECOND NEGATIVE COMMENT WAS FROM (B)(4) USER (B)(6) WHICH WAS FILED AND RELATED UNDER ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478248 UNSPECIFIED BD WINGSET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1