BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 12089440 · Received June 29, 2021

    Report

    Report Number
    1024879-2021-00437
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2021-07-12. INVESTIGATION SUMMARY BD RECEIVED ONE CUSTOMER PHOTO AND 5 SAMPLES (2 SAMPLES FROM LOT 1039412 AND 3 SAMPLES FROM LOT 0063477) FROM THE CUSTOMER FOR EVALUATION. THE PHOTO WAS EVALUATED AND THE INDICATED FAILURE MODE OF DAMAGED (CRACKED) / DISCOLORED WAS OBSERVED. THE 5 CUSTOMER SAMPLES WERE RECEIVED FROM BOTH LOTS, 2 SAMPLES FROM LOT 1039412 AND 3 SAMPLES FROM LOT 0063477. ALL SAMPLES WERE SUBJECTED TO A VISUAL INSPECTION FOR DISCOLORED/CRACKED, 2 SAMPLES FROM LOT 1039412 PASSED THE TEST WHILE ALL 3 SAMPLES FROM LOT 0063477 FAILED THE TEST. CONFIRMING THE COMPLAINT. IN ADDITION, 100 RETENTION SAMPLES FROM EACH LOT WERE SUBJECTED TO A VISUAL INSPECTION FOR DISCOLORED AND DAMAGED SLEEVES WITH NO DEFECTS OBSERVED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE WITH THE PHOTO AND SAMPLES PROVIDED. BD DETERMINED THE ROOT CAUSE IS ATTRIBUTED TO THE ASSEMBLY PROCESS IN WHICH A STRESSING OF THE SLEEVE CAN CAUSE DISCOLORATION AND THE APPEARANCE OF A TEAR (CRACK). IT IS NOT A FUNCTIONAL DEFECT; IT IS A COSMETIC DEFECT. THE SLEEVE DOES NOT TEAR, IT STILL FUNCTIONS AS IT IS DESIGNED TO. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SETS FAILED TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLACK PLASTIC COVERING FOR THE NEEDLE THAT GOES INTO BLOOD TUBE IS CRACKED, AND IS DISCOLORED WHITE. QUESTIONABLE IF OK TO USE, AND IF SMALL PIECES OF THE RUBBER COVERING WILL GO INTO BLOOD TUBE ON COLLECTION. DID NOT USE ON PATIENT, FOUND IN STOCK ROOM. NOT SURE IF PREVIOUS LOTS WERE USED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE TYPE: FPA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1039412. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. DEVICE MANUFACTURE DATE: 2021-02-08. MEDICAL DEVICE LOT #: 0063477. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2020-03-03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SETS FAILED TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLACK PLASTIC COVERING FOR THE NEEDLE THAT GOES INTO BLOOD TUBE IS CRACKED, AND IS DISCOLORED WHITE. QUESTIONABLE IF OK TO USE, AND IF SMALL PIECES OF THE RUBBER COVERING WILL GO INTO BLOOD TUBE ON COLLECTION. DID NOT USE ON PATIENT, FOUND IN STOCK ROOM. NOT SURE IF PREVIOUS LOTS WERE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985513 BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367364 SEE H.10. 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1