BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 11066232 · Received December 23, 2020

    Report

    Report Number
    1024879-2020-00946
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    December 1, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 2020-12-28. H6: INVESTIGATION SUMMARY: BD RECEIVED 13 SAMPLES AND 1 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR HUB/COLLAR SEPARATION AND BROKEN PIVOT SHIELD WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 13 CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR HUB/COLLAR SEPARATION IN 12 SAMPLES AND BROKEN PIVOT SHIELD WAS OBSERVED IN THE OTHER SAMPLE. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF HUB/COLLAR SEPARATION THROUGH A CORRECTIVE AND PREVENTIVE ACTION (CAPA)(B)(4). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE'S HUB SEPARATES FROM THE DEVICE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. IT IS REPORTED THE CUSTOMER WITNESSED HUB/ COLLAR SEPARATION. (2 OF 3). "MULTIPLE PHLEBOTOMISTS SENT SAMPLES WITH A COMPLAINT THAT THE SAFETY LOCK ON THE DEVICE GETS STUCK TO THE STERILE CAP DURING UNCAPPING. THESE ARE ALL FROM THE SAME LOT NUMBER 0211178 WITH EXP 07-31-2025."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE(S): 1506, FDA PATIENT PROBLEM CODE(S): 2199.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE'S HUB SEPARATES FROM THE DEVICE THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. IT IS REPORTED THE CUSTOMER WITNESSED HUB/ COLLAR SEPARATION. (2 OF 3). "MULTIPLE PHLEBOTOMISTS SENT SAMPLES WITH A COMPLAINT THAT THE SAFETY LOCK ON THE DEVICE GETS STUCK TO THE STERILE CAP DURING UNCAPPING. THESE ARE ALL FROM THE SAME LOT NUMBER 0211178 WITH EXP 07-31-2025."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526784 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 0211178 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1