BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PRECISIONGLIDE MULTIPLE SAMPLE NEEDLE

    MDR report key: 12081677 · Received June 28, 2021

    Report

    Report Number
    9617032-2021-00684
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 31, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-06-09. H6: INVESTIGATION SUMMARY: BD RECEIVED TWO (2) SAMPLES AND A PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR 'FOREIGN MATTER (FM) ON THE CANNULA' WITH THE INCIDENT LOT WAS OBSERVED. THE SAMPLES WERE SENT TO FRANKLIN LAKES FOR 'FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR)' ANALYSIS. BD WAS ABLE TO DETERMINE FROM FTIR ANALYSIS THAT THE FM CLOSELY RESEMBLES THE POLYSTYRENE HUB SPECTRUM. ADDITIONALLY, TEN (10) RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF 'FM ON THE CANNULA' WAS NOT OBSERVED. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO THE HUB SPRUE SEPARATION PROCESS. THE TEARING OF THE SPRUE FROM THE HUBS CAN RESULT IN CREATION OF SMALL PLASTIC PARTICULATES. THE PARTICULATES ARE COLLECTED ALONGSIDE HUBS IN THE MOULD COMPONENT BAGS AND THEN INTRODUCED TO THE MULTI-SAMPLE NEEDLE (MSN) LINE TOGETHER WITH THE HUBS. DURING MSN ASSEMBLY, THE PARTICULATES CAN DISLODGE FROM THE HUBS AND BECOME ADHERED TO THE LUBRICATION ON THE CANNULA. 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. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF 'FM (HUB)' THROUGH CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) 1240118. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GREEN FM ON MSN."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD RECEIVED TWO (2) SAMPLES AND PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR 'FOREIGN MATTER (FM) ON THE CANNULA' WITH THE INCIDENT LOT WAS OBSERVED. THE SAMPLES WERE SENT TO FRANKLIN LAKES FOR 'FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR)' ANALYSIS. BD WAS ABLE TO DETERMINE FROM FTIR ANALYSIS THAT THE FM CLOSELY RESEMBLES THE POLYSTYRENE HUB SPECTRUM. ADDITIONALLY, TEN (10) RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF 'FM ON THE CANNULA' WAS NOT OBSERVED. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO THE HUB SPRUE SEPARATION PROCESS. THE TEARING OF THE SPRUE FROM THE HUBS CAN RESULT IN CREATION OF SMALL PLASTIC PARTICULATES. THE PARTICULATES ARE COLLECTED ALONGSIDE HUBS IN THE MOULD COMPONENT BAGS AND THEN INTRODUCED TO THE MULTI-SAMPLE NEEDLE (MSN) LINE TOGETHER WITH THE HUBS. DURING MSN ASSEMBLY, THE PARTICULATES CAN DISLODGE FROM THE HUBS AND BECOME ADHERED TO THE LUBRICATION ON THE CANNULA. 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. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF 'FM (HUB)' THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER¿ PRECISIONGLIDE" MULTIPLE SAMPLE NEEDLE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GREEN FM ON MSN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976660 BD VACUTAINER PRECISIONGLIDE MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 0301643

    Patients

    Seq Age Sex Outcome Treatment
    1