BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER BLOOD COLLECTION SET

    MDR report key: 11809988 · Received May 11, 2021

    Report

    Report Number
    2243072-2021-01388
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO CORRECTIONS. THE MDR REPORT WAS DEEMED NOT REPORTABLE DUE TO THIS RECORD BEING A DUPLICATE, AND CAPTURED IN RECORD PR# 925650 MFR REPORT #: 1917413-2019-01458. MDR OWNERSHIP: MFR REPORT #: 1917413-2019-01458.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER® BLOOD COLLECTION SET, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD, AND OVERFILL . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT COAG TUBES ARE UNDER AND OVER FILLING. "IMPORTANT NOTICES, LIKE THE DISCONTINUATION OF A BLOOD COLLECTION TUBE, DID NOT GET TO THE PHLEBOTOMY SUPERVISOR AT A HOSPITAL. WE ARE ALSO NOTICING QUALITY ISSUES WITH PRODUCTS. BLOOD CULTURE BOTTLES NOT BEING FILLED WITH THE SAME UNIFORMITY, COAG TUBES UNDER AND OVER FILLING. " 5/27 -CANCELLATION REQUEST: THE CUSTOMER HAS CONFIRMED THAT THIS IS NOT A NEW ISSUE/OCCURRENCE, BUT RATHER THEY ARE REFERRING TO TUBE FILL ISSUES THAT THEY HAD BACK IN 2019. THE COMPLAINT THE CUSTOMER IS REFERRING TO IS PR#925650 WHICH ALREADY HAS AN MDR SUBMITTED FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER® BLOOD COLLECTION SET, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD, AND OVERFILL . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT COAG TUBES ARE UNDER AND OVER FILLING. "IMPORTANT NOTICES, LIKE THE DISCONTINUATION OF A BLOOD COLLECTION TUBE, DID NOT GET TO THE PHLEBOTOMY SUPERVISOR AT A HOSPITAL. WE ARE ALSO NOTICING QUALITY ISSUES WITH PRODUCTS. BLOOD CULTURE BOTTLES NOT BEING FILLED WITH THE SAME UNIFORMITY, COAG TUBES UNDER AND OVER FILLING. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705934 UNSPECIFIED BD VACUTAINER BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1