BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9364400 · Received November 22, 2019

    Report

    Report Number
    8041187-2019-00940
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 17, 2019
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHOTOS, ONE USED SAMPLE AND TWO REPRESENTATIVE SAMPLES (BATCH #8356828-1PCS AND BATCH #9052981-1PCS) WERE RETURNED FOR INVESTIGATION. THE RETURNED PHOTOS SHOW THE USED CANNULA HUB WITH CATHETER BROKEN. THE USED SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. A CLEAN CUT WAS OBSERVED ON THE HALF OF CATHETER. FROM THE BROKEN EDGE, IT COULD BE CUT BY SHARP OBJECT AND STRETCHED CAUSED THE BREAKAGE. THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND CATHETER ADAPTER LEAK TEST. NO ABNORMALITY WAS OBSERVED ON THE CATHETER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE RETURNED PHOTOS AND RETURNED USED SAMPLE. UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE REPRESENTATIVE SAMPLES RETURNED. CONCLUSION(S): THE USED SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. A CLEAN CUT WAS OBSERVED ON THE HALF OF CATHETER. FROM THE BROKEN EDGE, IT COULD BE CUT BY SHARP OBJECT AND STRETCHED CAUSED THE BREAKAGE. THE MANUFACTURING PROCESS HAS BEEN 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 PRODUCT 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 CATHETER IS BROKEN BEFORE USE. BASED ON THE INVESTIGATION AND ANALYSIS, THE REPORTED NONCONFORMANCE IS NOT CAUSED BY THE MANUFACTURING PROCESS. THE PROBABLE CAUSE OF THE BROKEN CATHETER COULD BE DUE TO CUT BY SHARP OBJECT SUCH AS SCISSORS DURING PRODUCT REMOVAL FROM VEIN. HOWEVER, USER WOULD HAVE READ AND FOLLOWED THE INSTRUCTION FOR USE IN THE SHELF BOX, WHICH STATES ¿DO NOT USE SCISSORS AT OR CLOSE TO THE INSERTION SITE.¿. THEREFORE, THE ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER WAS INSERTED AND WAS FLUSHED FOR SEVERAL DAYS WITH NO LEAKAGE AND SO SIGNS OF INFECTION, PHLEBITIS ETC. WHEN NURSE WAS REMOVING THE CANNULA IN PREPARATION FOR A NEW ONE TO BE INSERTED IT WAS DISCOVERED THAT THE DEVICE WAS ON PATIENTS ARM AND CATHETER WAS MISSING AND DISCOVERED TO REMAIN IN PATIENTS VEIN WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IN HOSPITAL LONG TERM IN MATERNITY WARD A. THE 3RD CANNULA DURING PATIENTS STAY WAS INSERTED INTO THE RIGHT ARM (FOREARM) WITHOUT ANY REPORTED DIFFICULTY ON THE (B)(6)2019. CANNULA WAS FLUSHED ON THE 26TH, 27TH, 28TH AND 29TH OF OCTOBER WITH SALINE. NO REPORTED DIFFICULTY OR LEAKAGE. NO SIGNS OF INFECTION, PHLEBITIS, EXTRAVASATION ETC. ON THE 30TH OF OCTOBER, NURSE WAS PROCEEDING TO REMOVE THE CANNULA IN PREPARATION FOR A NEW CANNULA TO BE INSERTED AS THE PATIENT WAS REMAINING IN HOSPITAL. ON REMOVING THE DRESSING THE NURSE NOTICED THE BODY OF THE CANNULA LYING ON THE PATIENTS ARM, AND THE CANNULA OF THE DEVICE WAS MISSING. THE PATIENTS ARM WAS SCANNED ON THE 31ST OCTOBER WHICH CONFIRMED THE CANNULA WAS STILL IN THE PATIENTS VEIN. CANNULA REMOVED BY A VASCULAR SURGEON ON THE 1ST OF NOVEMBER. PATIENT RECEIVED DISPOSABLE STITCHES. NO FURTHER TREATMENT REQUIRED. NO INJURY TO THE NURSE. DATEX AND NIAC FORMS COMPLETED. URSULA AWAITING INSTRUCTION FROM DATEX BEFORE SHE CAN GIVE ME THE AFFECTED SAMPLE. THEY DID NOT KEEP THE ORIGINAL PRODUCT PACKAGING. THEREFORE THEY CANNOT BE SURE OF THE LOT NO OF THE AFFECTED DEVICE. A NEW CANNULA WAS INSERTED INTO THE LEFT ARM ON THE 2ND OF NOVEMBER WITH NO NOTED DIFFICULTY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER WAS INSERTED AND WAS FLUSHED FOR SEVERAL DAYS WITH NO LEAKAGE AND SO SIGNS OF INFECTION, PHLEBITIS ETC. WHEN NURSE WAS REMOVING THE CANNULA IN PREPARATION FOR A NEW ONE TO BE INSERTED IT WAS DISCOVERED THAT THE DEVICE WAS ON PATIENTS ARM AND CATHETER WAS MISSING AND DISCOVERED TO REMAIN IN PATIENTS VEIN WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IN HOSPITAL LONG TERM IN MATERNITY WARD A. THE 3RD CANNULA DURING PATIENTS STAY WAS INSERTED INTO THE RIGHT ARM (FOREARM) WITHOUT ANY REPORTED DIFFICULTY ON THE (B)(6) 2019. CANNULA WAS FLUSHED ON THE (B)(6) WITH SALINE. NO REPORTED DIFFICULTY OR LEAKAGE. NO SIGNS OF INFECTION, PHLEBITIS, EXTRAVASATION ETC. ON THE (B)(6), NURSE WAS PROCEEDING TO REMOVE THE CANNULA IN PREPARATION FOR A NEW CANNULA TO BE INSERTED AS THE PATIENT WAS REMAINING IN HOSPITAL. ON REMOVING THE DRESSING THE NURSE NOTICED THE BODY OF THE CANNULA LYING ON THE PATIENTS ARM, AND THE CANNULA OF THE DEVICE WAS MISSING. THE PATIENTS ARM WAS SCANNED ON THE (B)(6) WHICH CONFIRMED THE CANNULA WAS STILL IN THE PATIENTS VEIN. CANNULA REMOVED BY A VASCULAR SURGEON ON THE (B)(6). PATIENT RECEIVED DISPOSABLE STITCHES. NO FURTHER TREATMENT REQUIRED. NO INJURY TO THE NURSE. DATEX AND NIAC FORMS COMPLETED. URSULA AWAITING INSTRUCTION FROM DATEX BEFORE SHE CAN GIVE ME THE AFFECTED SAMPLE. THEY DID NOT KEEP THE ORIGINAL PRODUCT PACKAGING. THEREFORE THEY CANNOT BE SURE OF THE LOT NO OF THE AFFECTED DEVICE. A NEW CANNULA WAS INSERTED INTO THE LEFT ARM ON THE (B)(6) WITH NO NOTED DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160228 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9052981

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention