BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 20905228 · Received December 11, 2024

    Report

    Report Number
    9617032-2024-01926
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 18, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903602132
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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: D4. MEDICAL DEVICE LOT #: 4003281. D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2028. H4. DEVICE MANUFACTURE DATE: 03-JAN-2024. D.4 UDI#: (B)(4). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR POOR NEEDLE POINT INTEGRITY AND FOREIGN MATTER WAS OBSERVED. THE FAILURE MODE OF LOOSE IV SHIELD WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES OF FOREIGN MATTER, POOR NEEDLE POINT INTEGRITY AND LOOSE IV SHIELD WERE 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 POOR NEEDLE POINT INTEGRITY AND FOREIGN MATTER. THIS COMPLAINT COULD NOT BE CONFIRMED FOR LOOSE IV SHIELD. 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 ONE (1) BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE, THE CUSTOMER NOTICED THAT THE NEEDLE HAD A BLUNT TIP, AND A DRIED WHITE MATERIAL ON THE NEEDLE BODY AND ALSO, THE WHITE NEEDLE PROTECTOR IS SOMETIMES FOUND TO BE LOOSE. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE, THE CUSTOMER NOTICED THAT THE NEEDLE HAD A BLUNT TIP, AND A DRIED WHITE MATERIAL ON THE NEEDLE BODY AND ALSO, THE WHITE NEEDLE PROTECTOR IS SOMETIMES FOUND TO BE LOOSE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889947 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 4003281 30382903602132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown