BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31G 8MM 100CT GR NO PT ROCHE

    MDR report key: 8356101 · Received February 20, 2019

    Report

    Report Number
    2243072-2019-00295
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 28, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THIS COMPLAINT WAS RE-EVALUATED AND DETERMINED TO BE NOT REPORTABLE: THIS COMPLAINT IS NOT MDR REPORTABLE. GENERAL DISSATISFACTION OF THE PRODUCT DOES NOT IMPACT THE INTENDED USE OF THE DEVICE WHICH WOULD LEAD TO SERIOUS INJURY OR THE CLINICIAN OR PATIENT.

    Additional Manufacturer Narrative · 0

    THE CHANGES ARE AS FOLLOWS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A PEN NDL 31G 8MM 100CT GR NO PT ROCHE HAD A BARCODE THAT DID NOT WORK WHEN SCANNING THE PRODUCT. D. 1 MEDICAL DEVICE TYPE: N/A. D.2. COMMON DEVICE NAME: PEN NDL 31G 8MM 100CT GR NO PT ROCHE. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.4 MEDICAL DEVICE CATALOG #: 320674 G.2 MANUFACTURING LOCATION: BECTON DICKINSON AND CO. G.5. PMA / 510(K)#: N/A .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 31G 8MM 100CT GR NO PT ROCHE HAD A BARCODE THAT DID NOT WORK WHEN SCANNING THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 31G 8MM 100CT GR NO PT ROCHE HAD A BARCODE THAT DID NOT WORK WHEN SCANNING THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UNSPECIFIED BD PEN NEEDLE HAD A BARCODE THAT DID NOT WORK WHEN SCANNING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149354 PEN NDL 31G 8MM 100CT GR NO PT ROCHE PEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other