BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ IV CANNULA

    MDR report key: 13760345 · Received March 14, 2022

    Report

    Report Number
    8041187-2022-00119
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 28, 2022
    Report Date
    April 1, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 23-MAR-2022. H.6. ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1050605; D.4. MEDICAL DEVICE EXPIRATION DATE: 28FEB2026; H.4. DEVICE MANUFACTURE DATE: 19FEB2021. D.4. MEDICAL DEVICE LOT #: 1112326; D.4. MEDICAL DEVICE EXPIRATION DATE: 30FEB2026; H.4. DEVICE MANUFACTURE DATE: 22APR2021. H.6. INVESTIGATION: EIGHT BOXES (365 PIECES MIXED WITH MULTIPLE BATCHES) OF REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES RECEIVED ARE BROKEN DOWN AS FOLLOWS: 26GA ¿ NON-REPORTED BATCH (BELONG TO PR#: (B)(4)). 1.BATCH 8109434 (CATALOG 391349) ¿ 2 PIECES; 2.BATCH 8172394 (CATALOG 391349) ¿ 2 PIECES; 3.BATCH 9317420 (CATALOG 391349) ¿ 3 PIECES; 4.BATCH 9317423 (CATALOG 391349) ¿ 8 PIECES; 5.BATCH 0169594 (CATALOG 391349) ¿ 74 PIECES; 6.BATCH 1077142 (CATALOG 391349) ¿ 25 PIECES; 7.BATCH 1077150 (CATALOG 391349) ¿ 50 PIECES; 8.BATCH 1140412 (CATALOG 391349) ¿ 50 PIECES. 24GA ¿ REPORTED BATCH. 1.BATCH 1050605 (CATALOG 391350) ¿ 56 PIECES; 2.BATCH 1077186 (CATALOG 391350) ¿ 45 PIECES; 3.BATCH 1112326 (CATALOG 391350) ¿ 50 PIECES. 47 OF THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, TIP OD MEASUREMENT, BEVEL ANGLE MEASUREMENT, AND PENETRATION TESTING. THESE SAMPLES PASSED ALL INSPECTIONS, AND NO ABNORMALITIES WERE OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE CUSTOMER VERBATIM, THE PROBABLE ROOT CAUSE FOR PEELBACK COULD BE DUE TO THE TUBING MATERIAL. A TREND FOR THE PEELBACK ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT. WE HAVE FUNDED A PROJECT, CAPA#81917 TO EXAMINE HOW TO FURTHER INCREASE THE ROBUSTNESS OF THE BD NEOFLON DEVICE AND PREVENT FUTURE OCCURRENCES OF THIS TYPE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ IV CANNULA HAD THE NEEDLE PIERCE THE CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "THEY EVEN HAVE NOTICED THAT THE NEEDLE SOMETIMES WOULD PIERCE THE TUBE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ IV CANNULA HAD THE NEEDLE PIERCE THE CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "THEY EVEN HAVE NOTICED THAT THE NEEDLE SOMETIMES WOULD PIERCE THE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281631 BD NEOFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown