BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON 2 PNK 20GA IV CANNULA

    MDR report key: 9512640 · Received December 23, 2019

    Report

    Report Number
    2243072-2019-02885
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 4, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLES OF (10) VENFLON 20GA FROM LOT # 9142810 PRODUCT # 391452 WITH THE REPORTED ISSUE OF "THE CATHETER BREAKS AND AS A RESULT THE PROCESS BECOMES PAINFUL AND DANGEROUS FOR THE PATIENT". THE DHR WAS REVIEWED AND NO NCP OR QN WAS RAISED ON THIS LOT DURING MANUFACTURING AND PRODUCTION OF THE LOT NUMBER 9142810 UNTIL LOT RELEASE. THE CUSTOMER RETURNED SAMPLE IS MADE AVAILABLE AND SHOWED NO EVIDENCE OF CANNULA TIP DAMAGE. THE PENETRATION TESTS PERFORMED ON BOTH CUSTOMER'S RETURNED AND RETAINED SAMPLES SHOWED THE CANNULA PENETRATION IN CONFORMANCE TO BD SPECIFICATIONS. THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE TEAM INVESTIGATED THE CUSTOMER RETURNED SAMPLES AND THE RETENTION SAMPLES OF MATERIAL NUMBER 391452 FOR BATCH NUMBER 9142810 FOR PENETRATION TESTS REPORT AND WE DID NOT FIND ANY DEFECT IN THE CUSTOMER SAMPLES OR THE RETENTION SAMPLES. . THE PENETRATION TESTS REPORTS PERFORMED ON THE CUSTOMER SAMPLES ARE WITHIN SPECIFICATIONS. THE EXACT ROOT CAUSE CANNOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. THE INFORMATION WILL BE CAPTURED IN THE TREND REPORTS AND MONITORED MONTHLY. COLLECTED DATA ARE REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BREAK OCCURRED DURING USE WITH A VENFLON 2 PNK 20GA IV CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THIS YEAR IT HAS BEEN REPORTED FROM THE HOSPITAL STAFF THAT THE CATHETER BREAKS (OBVIOUSLY UPON SKIN CONTACT) AND AS A RESULT THE PROCESS BECOMES PAINFUL AND DANGEROUS FOR THE PATIENT. THUS, WE REQUIRE FROM THE MANUFACTURER TO INVESTIGATE THE ROOT CAUSE FOR THIS NON-CONFORMITY AS WELL AS TO PROVIDE THEM WITHIN 15 DAYS WITH THE OUTCOME OF THE INVESTIGATION."

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. NON_REGISTERED FDA MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BREAK OCCURRED DURING USE WITH A VENFLON 2 PNK 20GA IV CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THIS YEAR IT HAS BEEN REPORTED FROM THE HOSPITAL STAFF THAT THE CATHETER BREAKS (OBVIOUSLY UPON SKIN CONTACT) AND AS A RESULT THE PROCESS BECOMES PAINFUL AND DANGEROUS FOR THE PATIENT. THUS, WE REQUIRE FROM THE MANUFACTURER TO INVESTIGATE THE ROOT CAUSE FOR THIS NON-CONFORMITY AS WELL AS TO PROVIDE THEM WITHIN 15 DAYS WITH THE OUTCOME OF THE INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308843 VENFLON 2 PNK 20GA IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 9142810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other