BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 19331435 · Received May 16, 2024

    Report

    Report Number
    9617032-2024-00759
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 19, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903602101
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 15-MAY-2024. INVESTIGATION SUMMARY MATERIAL #: 360210. LOT/BATCH #: 4003277. BD RECEIVED 1,400 SAMPLES, 1 PHOTO AND 1 VIDEO FOR INVESTIGATION. THE PHOTO AND VIDEO WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR INSUFFICIENT BLOOD FLOW AND FOREIGN MATTER WERE OBSERVED. FOUR HUNDRED (400) OF THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL DRAW TESTING AND THE INDICATED FAILURE MODE FOR INSUFFICIENT BLOOD FLOW WITH THE INCIDENT LOT WAS OBSERVED IN 130 OF THE SAMPLES. SEVENTY-FIVE (75) OF THESE SAMPLES WERE PUT UNDER PRESSURE AND THE BLOCKAGE WAS REMOVED FROM THE CANNULAS. THE BLOCKAGE APPEARED TO BE EXCESS LUBRICATION. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL DRAW TESTING AND THE ISSUE OF INSUFFICIENT BLOOD FLOW AND FOREIGN MATTER WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES INSUFFICIENT BLOOD FLOW AND FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. 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 WHILE USING BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES THERE WAS INSUFFICIENT BLOOD FLOW. A WHITE MATERIAL WAS OBSERVED ON THE CANNULA HUB POTENTIALLY CONTRIBUTING TO THE FLOW ISSUES. THERE WAS NO IMPACT TO THE PATIENT. REPORT 2 OF 7.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES THERE WAS INSUFFICIENT BLOOD FLOW. A WHITE MATERIAL WAS OBSERVED ON THE CANNULA HUB POTENTIALLY CONTRIBUTING TO THE FLOW ISSUES. THERE WAS NO IMPACT TO THE PATIENT. REPORT 2 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668189 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON, DICKINSON AND COMPANY (BD) 4003277 30382903602101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown