BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER

    MDR report key: 17153187 · Received June 19, 2023

    Report

    Report Number
    8041187-2023-00288
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 10, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903932269
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 21-JUNE-2023. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 3 REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CONNECTOR LOOSE WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. THE RETURNED PHOTO SHOWED A NON-BD PRODUCT, SO IT COULD NOT BE USED TO EVALUATE THE INCIDENT REPORTED. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE NO ABNORMALITIES OR DEFECTS OBSERVED. THE LUER CONES OF ALL THE RETURNED SAMPLES WERE MEASURED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER THE CATHETER COULD NOT PROPERLY CONNECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: UPDATE ON 24 MAY WE INFORM YOU THAT WE COLLECTED 3 PIECES FOR EACH CODE INDICATED, IN THE ATTACHED FORM FROM THE HOSPITAL THEY INDICATED AN INDICATIVE NUMBER AS THIS IS A PROBLEM THAT HAPPENS OFTEN AND THE DATE INDICATED IS ONE OF MANY. WE CONFIRM THAT THERE WERE NO PARTICULAR CONSEQUENCES FOR THE PATIENT AND THE OPERATOR. THE SAMPLES DID NOT COME INTO CONTACT WITH CHEMOTHERAPEUTIC AGENTS. WE HEREBY INFORM YOU THAT WE HAVE RECEIVED A REPORT REGARDING THE VENFLON PRO SAFETY, COD. 393224 LOT 1357424 AND 2111014, COD. 393226 LOT 2140881 AND COD. 393222 LOT 1176089. THEY REPORT THAT THEY HAVE ENCOUNTERED PROBLEMS WITH ADHESION BETWEEN THE DEVICE AND ITS CONICAL TUBE CONNECTOR RESULTING IN A HIGH RISK OF ACCIDENTAL BLOOD SPILLAGE. THEY SAY THAT THE VENFLON PRO SAFETY USED WITH THE CONNECTORS, OF WHICH WE ATTACH PHOTOS, WHICH THEY DO NOT PURCHASE FROM YOU, HAVING SILICONE THERE IS NO ADHESION. WE HAVE COLLECTED THE SAMPLES AVAILABLE TO RETURN TO YOU, WE AWAIT YOUR INSTRUCTIONS FOR RETURN "ADHESION PROBLEMS BETWEEN THE DEVICE AND ITS CONICAL TUBE CONNECTOR RESULTING IN A HIGH RISK OF ACCIDENTAL BLOOD SPILLAGE. SEVERAL BATCHES WERE PREDOMINANTLY INVOLVED WITH THE SIZE G20, IN RARE CASES ALSO SIZE G18 AND G22 WERE INVOLVED". THE DEVICE WAS USED, FIRST USE. NUMBER OF PIECES INVOLVED 10. NO CONSEQUENCES

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER THE CATHETER COULD NOT PROPERLY CONNECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: UPDATE ON 24 MAY. WE INFORM YOU THAT WE COLLECTED 3 PIECES FOR EACH CODE INDICATED, IN THE ATTACHED FORM FROM THE HOSPITAL THEY INDICATED AN INDICATIVE NUMBER AS THIS IS A PROBLEM THAT HAPPENS OFTEN AND THE DATE INDICATED IS ONE OF MANY. WE CONFIRM THAT THERE WERE NO PARTICULAR CONSEQUENCES FOR THE PATIENT AND THE OPERATOR. THE SAMPLES DID NOT COME INTO CONTACT WITH CHEMOTHERAPEUTIC AGENTS. WE HEREBY INFORM YOU THAT WE HAVE RECEIVED A REPORT REGARDING THE VENFLON PRO SAFETY, COD. 393224, LOT 1357424 AND 2111014, COD. 393226, LOT 2140881 AND COD. 393222, LOT 1176089. THEY REPORT THAT THEY HAVE ENCOUNTERED PROBLEMS WITH ADHESION BETWEEN THE DEVICE AND ITS CONICAL TUBE CONNECTOR RESULTING IN A HIGH RISK OF ACCIDENTAL BLOOD SPILLAGE. THEY SAY THAT THE VENFLON PRO SAFETY USED WITH THE CONNECTORS, OF WHICH WE ATTACH PHOTOS, WHICH THEY DO NOT PURCHASE FROM YOU, HAVING SILICONE THERE IS NO ADHESION. WE HAVE COLLECTED THE SAMPLES AVAILABLE TO RETURN TO YOU, WE AWAIT YOUR INSTRUCTIONS FOR RETURN "ADHESION PROBLEMS BETWEEN THE DEVICE AND ITS CONICAL TUBE CONNECTOR RESULTING IN A HIGH RISK OF ACCIDENTAL BLOOD SPILLAGE. SEVERAL BATCHES WERE PREDOMINANTLY INVOLVED WITH THE SIZE G20, IN RARE CASES ALSO SIZE G18 AND G22 WERE INVOLVED". THE DEVICE WAS USED, FIRST USE. NUMBER OF PIECES INVOLVED 10. NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778190 BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2140881 00382903932269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown