BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8428577 · Received March 18, 2019

    Report

    Report Number
    2243072-2019-00505
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 15, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET. D. 1 MEDICAL DEVICE TYPE: JKA/FPA. D.2. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET. D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD) ¿ SUMTER, SC / 29153, D.4 MEDICAL DEVICE CATALOG #: 367363, D.4. MEDICAL DEVICE LOT #: 8086751, D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4), G.2 MANUFACTURING LOCATION: BECTON, DICKINSON & CO., (BD) ¿ SUMTER, SC / 29153, G.5. PMA / 510(K)#: K153309.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET ARE NOT STAYING ON THE BACKEND NEEDLE OF THE ULTRATOUCH BLOOD COLLECTION SET. AFTER PLACEMENT OF THE TUBE INTO THE HOLDER ONTO THE BACKEND MULTI SAMPLE NEEDLE THE TUBE MIGRATES BACK OCCLUDING THE NEEDLE IN THE STOPPER AND STOPPING BLOOD FLOW INTO THE TUBE. THIS FORCES THE CLINICIAN TO FORCIBLY HOLD THE TUBE FORWARD IN THE HOLDER TO ENABLE BLOOD TO CONTINUE TO FLOW INTO THE TUBE. H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR TUBE PUSH OFF WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR TUBE PUSH OFF WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNKNOWN BD VACUTAINER¿ TUBESARE NOT STAYING ON THE BACKEND NEEDLE OF THE ULTRATOUCH BLOOD COLLECTION SET. AFTER PLACEMENT OF THE TUBE INTO THE HOLDER ONTO THE BACKEND MULTI SAMPLE NEEDLE THE TUBE MIGRATES BACK OCCLUDING THE NEEDLE IN THE STOPPER AND STOPPING BLOOD FLOW INTO THE TUBE. THIS FORCES THE CLINICIAN TO FORCIBLY HOLD THE TUBE FORWARD IN THE HOLDER TO ENABLE BLOOD TO CONTINUE TO FLOW INTO THE TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET ARE NOT STAYING ON THE BACKEND NEEDLE OF THE ULTRATOUCH BLOOD COLLECTION SET. AFTER PLACEMENT OF THE TUBE INTO THE HOLDER ONTO THE BACKEND MULTI SAMPLE NEEDLE THE TUBE MIGRATES BACK OCCLUDING THE NEEDLE IN THE STOPPER AND STOPPING BLOOD FLOW INTO THE TUBE. THIS FORCES THE CLINICIAN TO FORCIBLY HOLD THE TUBE FORWARD IN THE HOLDER TO ENABLE BLOOD TO CONTINUE TO FLOW INTO THE TUBE.

    Additional Manufacturer Narrative · 1

    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. 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 UNKNOWN BD VACUTAINER¿ TUBESARE NOT STAYING ON THE BACKEND NEEDLE OF THE ULTRATOUCH BLOOD COLLECTION SET. AFTER PLACEMENT OF THE TUBE INTO THE HOLDER ONTO THE BACKEND MULTI SAMPLE NEEDLE THE TUBE MIGRATES BACK OCCLUDING THE NEEDLE IN THE STOPPER AND STOPPING BLOOD FLOW INTO THE TUBE. THIS FORCES THE CLINICIAN TO FORCIBLY HOLD THE TUBE FORWARD IN THE HOLDER TO ENABLE BLOOD TO CONTINUE TO FLOW INTO THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220740 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 8086751

    Patients

    Seq Age Sex Outcome Treatment
    1 Other