BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PEN NEEDLES

    MDR report key: 8203871 · Received December 28, 2018

    Report

    Report Number
    3006948883-2018-00323
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 7, 2018
    Report Date
    January 2, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. 14 RETAINED SAMPLES HAVE BEEN TESTED ON THREAD FUNCTION AND CLOG TEST, ALL RESULTS MEET THE SPECIFICATION. DHR OF LOT 7061488 WAS REVIEWED AND NO QN FOUND. MANUFACTURE RECORDS 7061488 WERE REVIEWED, NO ABNORMALITY WAS FOUND. INVESTIGATION CONCLUSION: AFTER CUSTOMER VISIT AND FEEDBACK FROM SALES REPRESENTATIVE, IT WAS DETERMINED THAT THE INCIDENT WAS CAUSED BY CUSTOMER SINCE HE DIDN¿T INSTALL PEN NEEDLE INTO INJECTION PEN DIRECTLY. THIS WOULD CAUSE NEEDLE CLOG TO OCCUR. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE. RATIONALE: AS IT WAS DETERMINED THE INCIDENT WAS NOT RELATED TO A MANUFACTURING PROCESS, NO FORMAL CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ PEN NEEDLES WERE CLOGGED DURING INJECTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ PEN NEEDLES WERE CLOGGED DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044207 BD¿ PEN NEEDLES PEN NEEDLE FMF BD (SUZHOU) 7061488

    Patients

    Seq Age Sex Outcome Treatment
    1 Other