BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 17054734 · Received June 2, 2023

    Report

    Report Number
    9617032-2023-00662
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 5, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: "MATERIAL #: 360213. LOT/BATCH #: 2182361. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH BEING CONNECTED TO A HOLDER, AND NO ISSUES WERE OBSERVED RELATING TO HOLDER SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE HOLDER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS." H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH BEING CONNECTED TO A HOLDER, AND NO ISSUES WERE OBSERVED RELATING TO HOLDER SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE HOLDER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE THE NEEDLE AND HOLDER SEPARATED/SPUN OUT. THIS EVENT OCCURRED 2 TIMES. PATIENT 2 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I WOULD LIKE TO REPORT 2 INCIDENTS TODAY OF THE NEEDLE TWISTING OFF WHILST STILL IN PATIENTS ARM IN MY 0945 AT 1000 PATIENTS FOR PHLEBOTOMY. THE NEEDLE CAME OFF AND I HAD TO REMOVE IT AND RETRY PHLEBOTOMY ATTEMPT WITH SEPERATE NEEDLE. THE NEEDLES WHICH HAD COME LOOSE ALSO WOULD NOT REFIT BACK INTO SAFETY GUARD SO THERE WAS A SIGNIFICANT SAFETY RISK FOR A NEEDLESTICK INJURY."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE THE NEEDLE AND HOLDER SEPARATED/SPUN OUT. THIS EVENT OCCURRED 2 TIMES. PATIENT 2 OF 2 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I WOULD LIKE TO REPORT 2 INCIDENTS TODAY OF THE NEEDLE TWISTING OFF WHILST STILL IN PATIENTS ARM IN MY 0945 AT 1000 PATIENTS FOR PHLEBOTOMY. THE NEEDLE CAME OFF AND I HAD TO REMOVE IT AND RETRY PHLEBOTOMY ATTEMPT WITH SEPERATE NEEDLE. THE NEEDLES WHICH HAD COME LOOSE ALSO WOULD NOT REFIT BACK INTO SAFETY GUARD SO THERE WAS A SIGNIFICANT SAFETY RISK FOR A NEEDLESTICK INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648746 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 2182361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown