BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8870620 · Received August 7, 2019

    Report

    Report Number
    1024879-2019-01367
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 23, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER CONSISTING OF: 6 SAMPLES FROM LOT 9052668. 8 SAMPLES FROM LOT 9046648. BELOW IS THE SUMMARY OF INVESTIGATION THAT WAS PERFORMED: VISUAL INSPECTION WAS CONDUCTED ON ALL SAMPLES FOR UV ADHESIVE COVERAGE AND DAMAGE TO THE HUB. ALL SAMPLES WERE WITHIN SPECIFICATION. SAMPLES WERE TESTED FOR THE BD HOLDER UNTHREADING DURING USE BY DRAW TESTING SIX TUBES PER NEEDLE WITH WATER AS A TEST MEDIA. EACH OF THE SAMPLES DREW TUBES TO THE REQUIRED FILL-LINES WITHOUT ANY INDICATION OF THE HOLDER UNTHREADING FROM THE ECLIPSE UNIT. ADDITIONAL INSPECTION AND TESTING WERE PERFORMED ON RETENTION SAMPLES FROM THE KNOWN INCIDENT LOTS 9052668 AND 9046648 AND ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ADDITIONALLY, BD RECEIVED NINE (9) PHOTOS. NO ISSUES WERE ABLE TO BE IDENTIFIED FROM THE PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOTS AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAD FOREIGN MATTER WHICH MADE THE CONNECTION LOOSE. THIS OCCURRED ON 28 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS FM LIKE ADHESIVE ON THE SCREW CONNECTED WITH HOLDER. DUE TO FM LIKE ADHESIVE, THE CONNECTION IS LOOSE BETWEEN ECLIPSE AND HOLDER DURING USE. THE CUSTOMER FEELS VERY DANGEROUS. IN ADDITION, NP NEEDLE TOP IS HOOK. LOT IS UNKNOWN, BUT IT IS POSSIBLE THAT LOT IS 9046648 OR 9052668.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 9046648, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-02-15. MEDICAL DEVICE LOT #: 9052668, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-02-21. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAD FOREIGN MATTER WHICH MADE THE CONNECTION LOOSE. THIS OCCURRED ON 28 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS FM LIKE ADHESIVE ON THE SCREW CONNECTED WITH HOLDER. DUE TO FM LIKE ADHESIVE, THE CONNECTION IS LOOSE BETWEEN ECLIPSE AND HOLDER DURING USE. THE CUSTOMER FEELS VERY DANGEROUS. IN ADDITION, NP NEEDLE TOP IS HOOK. LOT IS UNKNOWN, BUT IT IS POSSIBLE THAT LOT IS 9046648 OR 9052668.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662212 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other