BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ IV CANNULA

    MDR report key: 9098375 · Received September 20, 2019

    Report

    Report Number
    8041187-2019-00743
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 25, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 3 PHOTOS,1 USED SAMPLE AND 1 REPRESENTATIVE SAMPLE WERE RECEIVED FOR INVESTIGATION. THE 1ST AND 2ND PHOTOS SHOW PEELBACK ON CATHETER TIP (24GA). THE 3RD PHOTO SHOWS 1PCS 24GA SAMPLE WITH PEELBACK ON CATHETER TIP AND 2 TOP WEB WITH BATCH#: 8201195 (24GA, CATALOG: 391350) AND #8052272 (26GA, CATALOG: 391349). THE USED SAMPLE (BATCH#: 8201195) WAS SUBJECTED TO VISUAL INSPECTION. PEELBACK WAS OBSERVED FROM THE USED SAMPLE RETURNED. THE 1 REPRESENTATIVE SAMPLE (BATCH#: 8201195) WAS SUBJECTED TO VISUAL INSPECTION, TIP OD MEASUREMENT AND BEVEL ANGLE MEASUREMENT. THE 1 REPRESENTATIVE SAMPLE PASSED THE ACCEPTANCE CRITERIA. NO ABNORMALITY WAS OBSERVED. THE PROBABLE ROOT CAUSE OF PEELBACK COULD BE DUE TO THE TUBING MATERIAL. CAPA#: 81917 WAS ISSUED TO REVIEW THE TUBING MATERIAL. OUR FACILITY HAS CONDUCTED A COMPETITIVE BENCHMARKING STUDY WAS CONDUCTED TO COMPARE PEEL BACK PERFORMANCE OF NEOFLON WITH KEY COMPETITORS IN INDIA MARKET. ALL THE COMPETITORS HAVE BETTER PEELBACK PERFORMANCE THAN NEOFLON. TO ADDRESS THIS EVENT OUR FACILITY HAS REDESIGNED THE DEVICE TO BE MANUFACTURED FROM MORE RELIABLE MATERIAL. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 8201195. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INJECTION THE CATHETER AND NEEDLE SEPARATED WITH A BD NEOFLON¿ IV CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE USED THE IV CANNULA G-24 NEOFLON BD THERE ARE LOT OF INSTANCES THAT WHEN WE INTRODUCED TO THE SKIN DURING IV CANNULATION, THE PLASTIC SLEEVE AND NEEDLE SEPARATED TO THE PLASTIC CATHETER.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 DURING INJECTION THE CATHETER AND NEEDLE SEPARATED WITH A BD NEOFLON¿ IV CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE USED THE IV CANNULA G-24 NEOFLON BD THERE ARE LOT OF INSTANCES THAT WHEN WE INTRODUCED TO THE SKIN DURING IV CANNULATION, THE PLASTIC SLEEVE AND NEEDLE SEPARATED TO THE PLASTIC CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891131 BD NEOFLON¿ IV CANNULA INTRAVACULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8201195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other