BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L

    MDR report key: 11675525 · Received April 15, 2021

    Report

    Report Number
    2243072-2021-01166
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE UNSPECIFIED BDVENFLON PRO SAFETY 22GA 0.9MM OD 25MM L LEAKED BLOOD/INFUSION DRUGS THROUGH THE INJECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER DESCRIBES AN EVENT WITH LEAKAGE THROUGH THE INJECTION PORT WITH CAP. UPDATE MARCH 22ND: CUSTOMER HAS NOT WITNESSED THE LEAKAGE, BUT IN THE ABOVE-MENTIONED CASE HAS SEEN BLOOD AND INFUSION-DRUGS RESIDUES UNDER THE IV-SECUREMENT (TEGADERM PATCH). THEY USE A SYRINGE PUMP THAT IS CONNECTED TO THE PIVC (DISTAL TO A BACK CHECK VALVE), THE PUMP IS RUN THROUGHOUT THE OPERATION. THEY MOST OFTEN LEAVE THE CAP TO THE INJECTION PORT OPEN TO ENABLE A RAPID ACCESS FOR PHARMACEUTICAL TREATMENT. CUSTOMER CONFIRMS THERE HAS BEEN NO HARM TO THE PATIENT. D1: MEDICAL DEVICE BRAND NAME: VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L; D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL (SINGAPORE); D4: CATALOG # 393222; D4: MEDICAL DEVICE LOT #: 0051160; D4: MEDICAL DEVICE EXPIRATION DATE: 2023-02-28; G2: MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL (SINGAPORE); H4: DEVICE MANUFACTURE DATE: 2020-02-20. D1: MEDICAL DEVICE BRAND NAME: VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL (SINGAPORE); D4: CATALOG # 393224; D4: MEDICAL DEVICE LOT #: 0165382; D4: MEDICAL DEVICE EXPIRATION DATE: 2023-06-30; G2: MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL (SINGAPORE); H4: DEVICE MANUFACTURE DATE: 2020-06-13. D1: MEDICAL DEVICE BRAND NAME: VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L; D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL (SINGAPORE); D4: CATALOG # 393226; D4: MEDICAL DEVICE LOT #: 0050294; D4: MEDICAL DEVICE EXPIRATION DATE: 2023-01-31; G2: MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL (SINGAPORE); H4: DEVICE MANUFACTURE DATE: 2020-02-19. H6: INVESTIGATION SUMMARY: THERE WAS NO SAMPLE OR PHOTO PROVIDED TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BD IS AWARE OF THIS ISSUE AND IS IN THE PROCESS OF IMPLEMENTING CORRECTIVE ACTIONS TO IMPROVE THE CUSTOMER AND PATIENT EXPERIENCE. CAPA 1379444 HAS BEEN INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BDVENFLON PRO SAFETY 22GA 0.9MM OD 25MM L LEAKED BLOOD/INFUSION DRUGS THROUGH THE INJECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER DESCRIBES AN EVENT WITH LEAKAGE THROUGH THE INJECTION PORT WITH CAP. UPDATE MARCH 22ND: CUSTOMER HAS NOT WITNESSED THE LEAKAGE, BUT IN THE ABOVE-MENTIONED CASE HAS SEEN BLOOD AND INFUSION-DRUGS RESIDUES UNDER THE IV-SECUREMENT (TEGADERM PATCH). THEY USE A SYRINGE PUMP THAT IS CONNECTED TO THE PIVC (DISTAL TO A BACK CHECK VALVE), THE PUMP IS RUN THROUGHOUT THE OPERATION. THEY MOST OFTEN LEAVE THE CAP TO THE INJECTION PORT OPEN TO ENABLE A RAPID ACCESS FOR PHARMACEUTICAL TREATMENT. CUSTOMER CONFIRMS THERE HAS BEEN NO HARM TO THE PATIENT."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. THE REPORTED LOT NUMBERS [0051160, 0165382, 0050294] WERE NOT FOUND TO MATCH ANY SINGLE MATERIAL#. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED BLOOD/INFUSION DRUGS THROUGH THE INJECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER DESCRIBES AN EVENT WITH LEAKAGE THROUGH THE INJECTION PORT WITH CAP. UPDATE MARCH 22ND: CUSTOMER HAS NOT WITNESSED THE LEAKAGE, BUT IN THE ABOVE-MENTIONED CASE HAS SEEN BLOOD AND INFUSION-DRUGS RESIDUES UNDER THE IV-SECUREMENT (TEGADERM PATCH). THEY USE A SYRINGE PUMP THAT IS CONNECTED TO THE PIVC (DISTAL TO A BACK CHECK VALVE), THE PUMP IS RUN THROUGHOUT THE OPERATION. THEY MOST OFTEN LEAVE THE CAP TO THE INJECTION PORT OPEN TO ENABLE A RAPID ACCESS FOR PHARMACEUTICAL TREATMENT. CUSTOMER CONFIRMS THERE HAS BEEN NO HARM TO THE PATIENT. CUSTOMER DOES NOT REMEMBER WHICH SKU WAS INVOLVED IN THIS CASE, MENTION 3 LOT FROM THE BOXES USED LAST THREE MONTHS (LOT: 0051160, 0165382, 0050294)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567240 VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0051160

    Patients

    Seq Age Sex Outcome Treatment
    1