BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8035063 · Received November 2, 2018

    Report

    Report Number
    3002682307-2018-00263
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE 2104 (JUNE 7-9TH 2018) DURING WHICH 62 VISUAL INSPECTIONS WERE CARRIED OUT WITH 1 REJECTION NOTED (#11101) RELATED TO DEFECTIVE PRINTING. ASSEMBLED NEEDLES COMES FROM TWO BATCHES: #8155999 (MACHINE 4408) JUNE 5-15TH, 2018 DURING WHICH 523 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. #8114505 (MACHINE 4407) APRIL 30 ¿ MAY 10TH, 2018 DURING WHICH 428 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. NO ABNORMALITIES OR ISSUES WERE DETECTED IN INJECTED HUB BATCHES (#8156536, #8085775 AND #8114508) RELATED TO CLOG ISSUE (MOLD MACHINE #3570 BETWEEN APRIL AND JUNE 2018). 1QN RELATED TO BURNT RESIN WAS REACHED (#10986), BUT IT WOULD NOT AFFECT THE REPORTED ISSUE. CANNULA BATCHES #808173, #8023734, #8130841 AND #8165813 SUPPLIER BY COLUMBUS PLANT. NO SAMPLES AVAILABLE. CONCLUSION(S): UNFORTUNATELY, NO SAMPLE HAS BEEN PROVIDED TO CONDUCT A DEEP INVESTIGATION, SO NO ADDITIONAL INFORMATION COULD BE ADDED TO PREVIOUS COMPLAINT INVESTIGATION RELATED #544292.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ BLUNT FILL NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 WITH THE USE OF THE BD¿ BLUNT FILL NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875511 BD¿ BLUNT FILL NEEDLE NEEDLE FMF BECTON DICKINSON, S.A. 180611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other