BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 7974658 · Received October 17, 2018

    Report

    Report Number
    3002682307-2018-00245
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 25, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    GAA
    UDI-DI
    00382903031290
    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: 180611: 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. 180616: 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 12-14TH, 2018) DURING WHICH 56 VISUAL INSPECTIONS WERE CARRIED OUT WITH 0 REJECTION NOTED. ASSEMBLED NEEDLES (#5155999) WERE ASSEMBLED IN MACHINE 4408 (JUNE 5-15TH, 2018) DURING WHICH 523 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, #8130841 AND #8165813 SUPPLIER BY COLUMBUS PLANT. BD HAS BEEN PROVIDED WITH 1 SAMPLE LOT 180611 (OPENED PACKAGE) AND 1 REFERENCE SAMPLE OF LOT 180616. VISUAL INSPECTION SHOW NO CLOGGED NEEDLE FOR LOT 180616. VISUAL EXAMINATION UNDER MICROSCOPE REVEAL A SOLID WHITE SUBSTANCE ON CANNULA SURFACE OF SAMPLE LOT 180611, RESULTING IN SMALL GRAINS WHITE MATERIAL APPEARED TO BE BEADS OF MATERIAL WHEN EXAMINED UNDER THE MICROSCOPE. SAMPLE OF LOT 180611 WAS CHARACTERIZED BY FTIR ANALYSIS SHOWS NO CONCLUSIVE MATCH WITH MATERIALS USED DURING MANUFACTURING PROCESS. CONCLUSION(S): NOT POSSIBLE TO DETERMINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ BLUNT FILL NEEDLES ARE CLOGGED AND DIRTY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 BD¿ BLUNT FILL NEEDLES ARE CLOGGED AND DIRTY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816642 BD¿ BLUNT FILL NEEDLE NEEDLE GAA BECTON DICKINSON, S.A. 180611 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other