BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 10564016 · Received September 21, 2020

    Report

    Report Number
    1024879-2020-00649
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.3. DATE OF EVENT: (B)(6) 2020. G.4. DATE RECEIVED BY MANUFACTURER: 2020-09-10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY SHIELDS BROKE OFF. THIS OCCURRED ON 2 SEPARATE OCCASIONS WITH LOT# 0003865 AND 3 OCCASIONS WITH LOT# 0030216, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY SHIELDS BROKE OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY SHIELDS BROKE OFF. THIS OCCURRED ON 2 SEPARATE OCCASIONS WITH LOT# 0003865 AND 3 OCCASIONS WITH LOT# 0030216, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY SHIELDS BROKE OFF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0003865 MEDICAL DEVICE EXPIRATION DATE: 2024-12-31 DEVICE MANUFACTURE DATE: 2020-01-03 MEDICAL DEVICE LOT #: 0030216 MEDICAL DEVICE EXPIRATION DATE: 2025-01-31 DEVICE MANUFACTURE DATE: 2020-01-30" THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 2020-08-19. MEDWATCH UF/IMPORTER REPORT # 0800040000-2020-8022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY SHIELDS BROKE OFF. THIS OCCURRED ON 2 SEPARATE OCCASIONS WITH LOT# 0003865 AND 3 OCCASIONS WITH LOT# 0030216, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SAFETY SHIELDS BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029110 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 SEE H.10 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other