BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 7874063 · Received September 13, 2018

    Report

    Report Number
    8041187-2018-00309
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    July 19, 2018
    Report Date
    September 19, 2018
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 3 PHOTOS WERE RETURNED FOR INVESTIGATION. THE FIRST PHOTO SHOWS THE CASE LABEL (CATALOG 393224, BATCH #8110190), THE SECOND PHOTO SHOWS THE SHELF LABEL (CATALOG 393222, BATCH #8110203), THE THIRD PHOTO SHOWS SHELF CARTONS OF CATALOG 393222, BATCH #8110203 IN CASE CARTON OF CATALOG 393224, BATCH #8110190. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE AUTO CARTONER PROCESS HAS BEEN REVIEWED AND THERE IS NO POSSIBILITY OF PRODUCT MIX. IT WAS OBSERVED FROM THE PHOTO RETURNED THAT THE TOP LID OF THE CASE CARTON HAS BEEN TAPE WITH A BROWN TAPE WHILE THE BOTTOM LID OF THE CASE CARTON HAS BEEN TAPE WITH TRANSPARENT TAPE. THE MANUFACTURING PROCESS HAS BEEN REVIEWED AND ONLY TRANSPARENT TAPE IS USED. INVESTIGATION CONCLUSION: THE NON-CONFORMANCE MAY HAPPEN IN MANUFACTURING FACILITIES OR OUTSIDE OF MANUFACTURING FACILITIES. WITHIN MANUFACTURING FACILITIES: THE PROBABLY ROOT CAUSE MAY BE DUE TO THE NEED TO HAVE HUMAN INTERVENTION FOR LABELING. MANUAL LABELING MAY BE REQUIRED WHEN THE AUTO CARTONER DID NOT AFFIX THE LABEL PROPERLY WHICH RESULTED IN NO LABEL OR THE LABEL MAY BE DEFECTIVE AND REJECTED BY THE VISION CAMERA. IN SUCH SITUATION, THE OPERATOR WILL NEED TO OPEN UP THE CASE CARTON TO CHECK THE CONTENT IN THE CASE CARTON AND MANUALLY PRINT A NEW LABEL FROM THE PRINTER TO PASTE ON THE CASE CARTON. FOR THIS COMPLAINT CASE, THE OPERATOR COULD HAVE CHECKED THE CASE CARTON CONTENT BUT PRINTED THE WRONG CATALOG AND PASTED ON THE CASE CARTON. OUTSIDE OF MANUFACTURING FACILITIES: IT WAS OBSERVED ON THE RETURNED PHOTO THAT THE TOP LID OF THE CASE CARTON HAS BEEN TAPE WITH A BROWN TAPE WHILE THE BOTTOM LID OF THE CASE CARTON HAS BEEN TAPE WITH TRANSPARENT TAPE. THE MANUFACTURING PROCESS HAS BEEN REVIEWED AND ONLY TRANSPARENT TAPE IS USED. THEREFORE, THERE MAY BE HUMAN INTERVENTION ON CASE CARTON OUTSIDE OF MANUFACTURING FACILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX OF BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS HAD INCORRECT PRODUCT INSIDE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 THE BOX OF BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS HAD INCORRECT PRODUCT INSIDE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713925 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8110190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other