BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOFLON YEL 24GA IV CANNULA

    MDR report key: 8729075 · Received June 24, 2019

    Report

    Report Number
    8041187-2019-00485
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 18, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED DUE TO CORRECTED INFORMATION: H.1. TYPE OF REPORTABLE EVENT: SERIOUS INJURY. H.6. INVESTIGATION: 3 USED SAMPLES (BATCH #7323158-1PCS, #8109407-1PCS AND #8094499-1PCS) WERE RETURNED FOR INVESTIGATION. THE USED SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. PEELBACK WAS OBSERVED ON THE USED SAMPLES. THE COMPLAINT IS CONFIRMED AND PRODUCT IS OUT OF SPECIFICATION. THE PROBABLE ROOT CAUSE FOR PEELBACK COULD BE DUE TO TUBING MATERIAL. CAPA#81917 WAS ISSUED TO REVIEW THE TUBING MATERIAL. DHR WAS PERFORMED AND NO QN OR ABNORMALITY WAS OBSERVED THAT COULD HAVE INFLUENCED THE ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEOFLON YEL 24GA IV CANNULAS CAUSED MEDICAL INTERVENTION IN THE FORM OF A BOLUS DOSAGE DUE TO A DELAY IN TREATMENT CAUSED BY AN INABILITY TO APPLY THE CATHETER. THE INCIDENT TOOK PLACE DURING USE OF THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LAST YEAR CUSTOMER REPORTED A COMPLAINT REGARDING NEOFLON - PURPLE AND YELLOW. RECENTLY THEY WERE EXPERIENCING THE SAME PROBLEM. CATHETER PEELS BACK AND THEREFORE NEONATE HAD TO BE PUNCTURED SEVERAL TIMES. LATER START WITH FLUID/MEDICATION. SOMETIMES A HIGHER DOSAGE TO MAKE UP FOR LOST TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8109407, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-04-19. MEDICAL DEVICE LOT #: 8052236, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-03-15. MEDICAL DEVICE LOT #: 7354447, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-02-08. 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 AN UNSPECIFIED NUMBER OF NEOFLON YEL 24GA IV CANNULAS CAUSED MEDICAL INTERVENTION IN THE FORM OF A BOLUS DOSAGE DUE TO A DELAY IN TREATMENT CAUSED BY AN INABILITY TO APPLY THE CATHETER. THE INCIDENT TOOK PLACE DURING USE OF THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LAST YEAR CUSTOMER REPORTED A COMPLAINT REGARDING NEOFLON - PURPLE AND YELLOW. RECENTLY THEY WERE EXPERIENCING THE SAME PROBLEM. CATHETER PEELS BACK AND THEREFORE NEONATE HAD TO BE PUNCTURED SEVERAL TIMES. LATER START WITH FLUID/MEDICATION. SOMETIMES A HIGHER DOSAGE TO MAKE UP FOR LOST TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523093 NEOFLON YEL 24GA IV CANNULA INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other