BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 15290744 · Received August 25, 2022

    Report

    Report Number
    8041187-2022-00491
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    July 29, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1231178; MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024; DEVICE MANUFACTURE DATE: 04-OCT-2021. MEDICAL DEVICE LOT #: 2084856; MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025; DEVICE MANUFACTURE DATE: 09-MAY-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES D.10. RETURNED TO MANUFACTURER ON: 30-SEP-2022 H.6. INVESTIGATION SUMMARY: TWO PHOTOS AND SEVEN REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE RETURNED PHOTOS SHOW A USED (CONTAMINATED) 20G VENFLON PRO SAFETY CANNULA HUB WITHOUT THE CATHETER. HOWEVER, THE CATHETER DEFECT COULD NOT BE SEEN CLEARLY FROM THE PHOTOS RETURNED. THE SEVEN REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, CATHETER ADAPTER LEAK TESTING, AND THE CATHETER PULL TEST. ALL SAMPLES PASSED INSPECTION, AND NO ABNORMALITIES WERE OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE MANUFACTURING PROCESS WAS REVIEWED AND THERE ARE NO SHARP EDGES THAT COULD POSSIBLY COME INTO CONTACT WITH THE CATHETER TO CAUSE THE CUT. THERE IS AN AUTOMATED VISION INSPECTION SYSTEM THAT CAN DETECT AND REJECT PRODUCTS NOT MEETING THE LIE DISTANCE REQUIREMENT. IF THE CATHETER IS BROKEN IN THE MANUFACTURING PROCESS, THE DEFECTIVE PART WOULD BE REJECTED BY THE AUTOMATED VISION INSPECTION SYSTEM AS THE PRODUCT WILL NOT HAVE ANY LIE DISTANCE. IT WOULD ALSO NOT BE POSSIBLE TO USE THE PRODUCT IF THE CATHETER IS BROKEN BEFORE USE. THE PROBABLE ROOT CAUSE FOR THE BROKEN CATHETER COULD BE DUE TO THE CATHETER BEING CUT BY A SHARP OBJECT SUCH AS SCISSORS DURING PRODUCT REMOVAL FROM THE VEIN. AS IT IS STATED IN THE INSTRUCTIONS FOR USE, ¿DO NOT USE SCISSORS AT OR CLOSE TO THE INSERTION SITE¿. AS THE ACTUAL SAMPLE AND CATHETER TUBING WAS NOT RETURNED, IT IS NOT POSSIBLE TO DETERMINE WHAT HAPPENED TO THE PRODUCT. THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER BROKE FROM THE HUB AND COULDN'T BE FOUND. A CT SCAN WAS PERFORMED ON THE CHEST AND RIGHT UPPER LIMB, BUT THE FOREIGN BODY COULD NOT BE LOCATED. THE EVENT OF THE CATHETER BREAKING FROM THE HUB OCCURRED ONCE EACH IN LOTS 1231178 AND 2084856. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: A 20 G BD VENFLON PRO SAFETY PERIPHERAL VENOUS CATHETER WAS PLACED ON THE RIGHT HAND OF THE PATIENT ON 27/7. AT 11.10 P.M. ON 29/7, DURING THE NURSING ROUNDS, THE VENFLON WAS PRESENTED RAISED 90 DEGREES TO THE SKIN PLANE. AT THAT TIME THE PVC WAS NOT CONNECTED TO INFUSION BUT CLOSED WITH A NEUTRACLEAR NFC. UPON REMOVAL OF THE DRESSING PARTIALLY RAISED, THE OUTSIDE OF THE DEVICE WAS WITHOUT A CATHETER AND ON PALPATION NOT PRESENT IN THE VEIN. ON 30/7 THE CT SCAN OF THE CHEST AND RIGHT UPPER LIMB WAS NEGATIVE FOR THE PRESENCE OF A FOREIGN BODY. ON 1/8 A SURGICAL EXAMINATION WITH ULTRASOUND EXAMINATION WAS PERFORMED WHICH CONFIRMED THE ABSENCE OF THE FOREIGN BODY." "AT THE BEGINNING OF THE SHIFT THE PATIENT IS FOUND WITH THE PVC (PLACED IN THE RIGHT HAND) WITH THE OUTER PART OF THE PVC TURNED UPWARDS BY 90 DEGREES,DESPITE THE ANCHOR PATCH BEING FIRMLY ATTACHED TO THE VENFLON ITSELF AND THE SKIN. IN AN ATTEMPT TO RECORD IT CORRECTLY, WE DISCOVERED THAT THE EXTERNAL PART OF THE DEVICE WAS DISLODGED/ WITHOUT THE INTERNAL CANNULA, WHICH WAS NOT IN THE BED AND WAS NOT DETECTED UPON PALPATION DURING ALONG THE VENOID PATH. VITALS FOUND TO BE NORMAL. CONTACTED DOCTOR ON DUTY AND REQUESTED AND PERFORMED URGENT BLANK CT SCAN WITH NO RESPONSE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER BROKE FROM THE HUB AND COULDN'T BE FOUND. A CT SCAN WAS PERFORMED ON THE CHEST AND RIGHT UPPER LIMB, BUT THE FOREIGN BODY COULD NOT BE LOCATED. THE EVENT OF THE CATHETER BREAKING FROM THE HUB OCCURRED ONCE EACH IN LOTS 1231178 AND 2084856. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: A 20 G BD VENFLON PRO SAFETY PERIPHERAL VENOUS CATHETER WAS PLACED ON THE RIGHT HAND OF THE PATIENT ON (B)(6). AT 11.10 P.M. ON (B)(6), DURING THE NURSING ROUNDS, THE VENFLON WAS PRESENTED RAISED 90 DEGREES TO THE SKIN PLANE. AT THAT TIME THE PVC WAS NOT CONNECTED TO INFUSION BUT CLOSED WITH A NEUTRACLEAR NFC. UPON REMOVAL OF THE DRESSING PARTIALLY RAISED, THE OUTSIDE OF THE DEVICE WAS WITHOUT A CATHETER AND ON PALPATION NOT PRESENT IN THE VEIN. ON (B)(6) THE CT SCAN OF THE CHEST AND RIGHT UPPER LIMB WAS NEGATIVE FOR THE PRESENCE OF A FOREIGN BODY. ON 1/8 A SURGICAL EXAMINATION WITH ULTRASOUND EXAMINATION WAS PERFORMED WHICH CONFIRMED THE ABSENCE OF THE FOREIGN BODY." "AT THE BEGINNING OF THE SHIFT THE PATIENT IS FOUND WITH THE PVC (PLACED IN THE RIGHT HAND) WITH THE OUTER PART OF THE PVC TURNED UPWARDS BY 90 DEGREES,DESPITE THE ANCHOR PATCH BEING FIRMLY ATTACHED TO THE VENFLON ITSELF AND THE SKIN. IN AN ATTEMPT TO RECORD IT CORRECTLY, WE DISCOVERED THAT THE EXTERNAL PART OF THE DEVICE WAS DISLODGED/ WITHOUT THE INTERNAL CANNULA, WHICH WAS NOT IN THE BED AND WAS NOT DETECTED UPON PALPATION DURING ALONG THE VENOID PATH. VITALS FOUND TO BE NORMAL. CONTACTED DOCTOR ON DUTY AND REQUESTED AND PERFORMED URGENT BLANK CT SCAN WITH NO RESPONSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235687 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention