BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 8884648 · Received August 12, 2019

    Report

    Report Number
    1024879-2019-01408
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    June 25, 2019
    Report Date
    August 27, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686563
    PMA / PMN Number
    K011984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: AS OF AUGUST 2, 2019 THIS COMPLAINT IS UNDER THE SCOPE OF FIELD ACTION # PAS-19-1567: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#982194 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    E.4. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (07/11/2019) VIA MEDWATCH # MW5087780.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE DEVICE FELL APART AFTER USE WHEN BUTTON WAS PUSHED TO RETRACT THE NEEDLE AND LEFT THE NEEDLE UNPROTECTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE DEVICE FELL APART AFTER USE WHEN BUTTON WAS PUSHED TO RETRACT THE NEEDLE AND LEFT THE NEEDLE UNPROTECTED."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI/JKA. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6), USA HAS BEEN USED AS A DEFAULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE DEVICE FELL APART AFTER USE WHEN BUTTON WAS PUSHED TO RETRACT THE NEEDLE AND LEFT THE NEEDLE UNPROTECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676371 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON & CO., (BD) 9091626 50382903686563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other