BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9696131 · Received February 11, 2020

    Report

    Report Number
    8041187-2020-00071
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 22, 2020
    Report Date
    January 24, 2020
    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 · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9208046. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-07-27. MEDICAL DEVICE LOT #: 9241529. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2019-08-29. INVESTIGATION SUMMARY: AS NO SAMPLE AND NO PHOTO WAS RETURNED, A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WAS PERFORMED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT WILL BE REOPENED WHEN SAMPLE IS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE AS NO SAMPLE AND NO PHOTO WAS RETURNED. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT TREND WOULD BE MONITORED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONTRAST MEDIUM LEAKED FROM THE TOP OF THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER'S CAP DURING USE. THE CATHETER HAD BEEN PLACED IN THE PATIENT'S ELBOW IN THE MEDIAN VEIN, AND THE NACL FLUSH BEFOREHAND "WENT SMOOTHLY". A FLOW OF "4.0ML/S" WAS USED FOR THE CONTRAST DOSE, AND THE PRESSURE REPORTEDLY ROSE "QUICKLY" AND DECREASED "ABRUPTLY" IN THE BEGINNING. AN EXTRA SCAN WAS DONE AS A RESULT OF THE LEAKAGE, AND THE CONTRAST WAS REMOVED FROM THE SCANNER. LOT#'S 9208046 AND 9241529 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PLACING OF THE VENFLON WENT SMOOTHLY, IT WAS PLACED IN THE MEDIAN VEIN IN THE ELBOW. THERE WAS NO DOUBT AT ALL THAT IT WOULD NOT SIT PROPERLY, AS THE NACL FLUSH WENT SMOOTHLY AND ALSO THE CONTROL THAT BLOOD WAS COMING BACK. A FLOW OF 4.0ML/S WAS CHOSEN FOR THE CONTRAST DOSE, WHICH IS NORMALLY NOT A PROBLEM WITH THIS SIZE OF VENFLONS. DURING THE START OF THE CONTRAST BOLUS, THE PRESSURE QUICKLY WENT UP, TO ALSO DECREASE ABRUPTLY. AT FIRST WE THOUGHT THAT THE ARM HAD BEEN BENT TOO MUCH, BUT THE PATIENT INDICATED THAT IT HAD NOT AND ALSO CLEARLY INDICATED THAT HE HAD MAINTAINED THE POSTURE AS INSTRUCTED. THERE WAS ALSO NO CONTRAST EXTRAVASATION. AFTER AN EXTRA CHECK WITH NACL WE WERE STILL CONVINCED THAT THE VENFLON WAS WELL IN THE VEIN. ON THIS SECOND ATTEMPT, I STAYED WITH THE PATIENT FOR A CHECK-UP. THEN IT APPEARED DURING THE NEW ATTEMPT TO CONTRAST VENOUS THAT THE CONTRAST MEDIUM CAME OUT THROUGH THE TOP/PINK CAP!" "MADE EXTRA SCAN, REMOVE CONTRAST FROM THE SCANNER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160431 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other