BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9401508 · Received December 3, 2019

    Report

    Report Number
    1710034-2019-01284
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 10, 2019
    Report Date
    February 19, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673242
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR NEEDLE STICK AND RETRACTION ISSUE WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND NEEDLE STICK AND RETRACTION ISSUE WAS OBSERVED. 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 1172284 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DID NOT FULLY RETRACT DURING USE AFTER COMPLETING THE BLOOD DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A STAFF EXPOSURE EARLY SUNDAY MORNING BECAUSE THE NEEDLE DID NOT RETRACT ALL THE WAY WHEN THE PHLEB WAS DONE WITH THE DRAW. I HAVE THE USED BUTTERFLY WITH ITS PACKAGING IF THEY NEED TO SEE IT."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE TYPE: FPA. THE REPORTED LOT # [9213645] WAS NOT FOUND FOR THE REPORTED CATALOG # [367324]. 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 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DID NOT FULLY RETRACT DURING USE AFTER COMPLETING THE BLOOD DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A STAFF EXPOSURE EARLY SUNDAY MORNING BECAUSE THE NEEDLE DID NOT RETRACT ALL THE WAY WHEN THE PHLEB WAS DONE WITH THE DRAW. I HAVE THE USED BUTTERFLY WITH ITS PACKAGING IF THEY NEED TO SEE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195594 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367324 UNKNOWN 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other