BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ IV CANNULA

    MDR report key: 8890871 · Received August 13, 2019

    Report

    Report Number
    8041187-2019-00630
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    May 20, 2016
    Report Date
    September 11, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 7 PHOTOS AND 2 USED SAMPLES WERE RETURNED FOR INVESTIGATION. 7 PHOTOS WERE RETURNED FOR INVESTIGATION. THE 1ST PHOTO SHOWS 2PCS SAMPLES AND THE TOP WEB WITH BATCH #5043217. THE 2ND TO 5TH PHOTOS SHOW 2PCS SAMPLES OF THE CATHETER CONDITION, PEELBACK WAS OBSERVED OF 1 OF THE SAMPLES. THE 6TH AND 7TH PHOTOS SHOW THE FIBER-LIKE FOREIGN MATTER. THE USED SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. PEELBACK WAS OBSERVED ON THE CATHETER TIP AND FIBER-LIKE FOREIGN MATTER WAS OBSERVED ON THE CATHETER. PEELBACK: THE PROBABLE ROOT CAUSE FOR PEELBACK COULD BE DUE TO TUBING MATERIAL. CAPA#81917 WAS ISSUED TO REVIEW THE TUBING MATERIAL. FOREIGN MATTER: BASED ON THE LABORATORY TEST REPORT, THE FOREIGN MATTER MATCHES THAT OF CELLULOSE. CELLOPHANE IS A DERIVATIVE OF CELLULOSE. PAPER, WOOD, COTTON AND SIMILAR MATERIALS ARE ALSO COMPOSED OF CELLULOSE. AS THE SAMPLE RECEIVED IS A USED SAMPLE, THE FM COULD EITHER BE FROM THE MANUFACTURING PLANT OR THE FM COULD BE ATTACHED TO THE CATHETER DURING PRODUCT APPLICATION. MANUFACTURING PROCESS HAS BEEN REVIEWED. THE FM COULD COME FROM PAPER USE FOR DOCUMENTATION OR COTTON FROM CLOTHING. A GMP AWARENESS TRAINING HAS BEEN PERFORMED FOR ALL ASSOCIATES WORKING IN NEOFLON PRODUCTION LINE AND THIS COMPLAINT BATCH WAS PRODUCED BEFORE THE TRAINING DATES. THE FM COULD ALSO COME FROM COTTON USE FOR ANTISEPTIC SWAP ON PATIENT'S SKIN PRIOR TO PRODUCT APPLICATION. THE FM COULD HAD ATTACHED ONTO THE CATHETER OF THE PRODUCT. A REVIEW OF 12 MONTHS QN ON REPORTED NONCONFORMANCE WAS PERFORMED. NO RELATED QN WAS RAISED. THEREFORE THE ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD NEOFLON¿ IV CANNULA HAD DAMAGED CATHETER TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CATHETER TIPS WERE DAMAGED LIKE BROKEN, TORN ETC. THE ISSUE OCCURRED 9 TIMES SINCE (B)(6) 2014. THIS PR IS FOR LOT#5043217.

    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 BEFORE USE OF THE BD NEOFLON¿ IV CANNULA HAD DAMAGED CATHETER TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CATHETER TIPS WERE DAMAGED LIKE BROKEN, TORN ETC. THE ISSUE OCCURRED 9 TIMES SINCE APRIL 2ND 2014. THIS PR IS FOR LOT#5043217.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684313 BD NEOFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 5043217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other