BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ 26GA 0.6MM OD 19MM L

    MDR report key: 9105389 · Received September 23, 2019

    Report

    Report Number
    8041187-2019-00746
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 10, 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

    INVESTIGATION SUMMARY: 3 PHOTOS WERE RETURNED 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). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. THE 1 REPRESENTATIVE SAMPLE (BATCH #8052272) WAS SUBJECTED TO VISUAL INSPECTION, TIP OD MEASUREMENT AND BEVEL ANGLE MEASUREMENT. THE 1 REPRESENTATIVE SAMPLE PASSED THE ACCEPTANCE CRITERIA. NO ABNORMALITY WAS OBSERVED. ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE PHOTOS RETURNED. CONCLUSION: THE PROBABLE ROOT CAUSE OF PEELBACK COULD BE DUE TO THE TUBING MATERIAL. CAPA#81917 WAS ISSUED TO REVIEW THE TUBING MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD NEOFLON¿ 26GA 0.6MM OD 19MM THE PLASTIC SLEEVE AND NEEDLE SEPARATE TO THE PLASTIC CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE USED THE IV CANNULA G-26 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

    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 USE OF THE BD NEOFLON¿ 26GA 0.6MM OD 19MM THE PLASTIC SLEEVE AND NEEDLE SEPARATE TO THE PLASTIC CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE USED THE IV CANNULA G-26 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
    901612 BD NEOFLON¿ 26GA 0.6MM OD 19MM L INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8052272

    Patients

    Seq Age Sex Outcome Treatment
    1 Other