BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 17845947 · Received September 29, 2023

    Report

    Report Number
    1024879-2023-00662
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D.1 MEDICAL DEVICE TYPE: FPA. D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 367364, LOT/BATCH #: 2230226 AND 2230228. BD RECEIVED 2 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR DIFFICULT TO RETRACT WITH THE INCIDENT LOT WAS NOT OBSERVED AS BOTH SAMPLES HAD A FULLY RETRACTED NEEDLE. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH HAVING THEIR SAFETY FEATURE ACTIVATED, AND UPON COMPLETION THE INDICATED FAILURE MODE FOR DIFFICULT TO RETRACT WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED A QUALITY NOTIFICATION WAS RAISED FOR THIS ISSUE. HOWEVER, LOT PASSED ALL IN-PROCESS AND FINAL QUALITY CHECKS FOR LOT RELEASE. WHILE BD WAS UNABLE TO CONFIRM THIS COMPLAINT FOR THE INDICATED FAILURE MODE DIFFICULT TO RETRACT WITH THE SAMPLES PROVIDED, BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF DIFFICULT TO RETRACT, AS FOUND IN OTHER COMPLAINTS, THROUGH CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 2 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THE BUTTON WAS DIFFICULT TO PRESS DURING RETRACTION AND DID NOT WORK PROPERLY. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE BUTTON WAS DIFFICULT TO PRESS. THE BUTTON TO MOVE THE NEEDLE WAS DIFFICULT TO PRESS AND DID NOT WORK PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 2 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THE BUTTON WAS DIFFICULT TO PRESS DURING RETRACTION AND DID NOT WORK PROPERLY. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE BUTTON WAS DIFFICULT TO PRESS. THE BUTTON TO MOVE THE NEEDLE WAS DIFFICULT TO PRESS AND DID NOT WORK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353118 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown