BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON I 18GA 1.2 MM X 45MM

    MDR report key: 12185874 · Received July 16, 2021

    Report

    Report Number
    2243072-2021-01899
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 16, 2021
    Report Date
    September 8, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF VENFLON I FROM LOT # 1101912 REGARDING ITEM #391593 WITH THE REPORTED ISSUE THAT ¿PACKING IS NOT GOOD ( NEW PACKING ) BOTH THE SIDES OPEN¿. NO SAMPLES AND TWO PHOTOGRAPHS HAVE BEEN RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECT. THE INVESTIGATING TEAM ALSO USED THE RETENTION SAMPLES OF MATERIAL CODE 391593 AND LOT NUMBER 1101912 FOR INVESTIGATING THE REPORTED DEFECT. THE DHR OF MATERIAL NUMBER 391593 AND LOT NUMBER 1101912 TO CHECK FOR ANY QUALITY NOTIFICATION AND NO QUALITY NOTIFICATION WAS RECORDED ON THIS LOT. BASED ON THE PHOTOGRAPHS SHARED BY THE CUSTOMER, THE DEFECT IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON I 18GA 1.2 MM X 45MM PACKAGING HAD POOR PERFORATION. THIS OCCURRED ON 250 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FEEDBACK FROM CUSTOMER ( SUB STOCKIEST ) REG VENFLON I PACKING IS NOT GOOD ( NEW PACKING ). BOTH THE SIDES OPEN, NOT CLOSED BOTH THE SIDES WITH TAPE OR PLASTER. CANNULAS ARE DROPPING FROM THE CARTON ON PICK UP FROM THE CASE BOX, VERY INCONVENIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF VENFLON I FROM LOT # 1101912 REGARDING ITEM #391593 WITH THE REPORTED ISSUE THAT ¿PACKING IS NOT GOOD ( NEW PACKING ) BOTH THE SIDES OPEN¿. NO SAMPLES AND TWO PHOTOGRAPHS HAVE BEEN RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECT. THE INVESTIGATING TEAM ALSO USED THE RETENTION SAMPLES OF MATERIAL CODE 391593 AND LOT NUMBER 1101912 FOR INVESTIGATING THE REPORTED DEFECT. BASED ON THE PHOTOGRAPHS SHARED BY THE CUSTOMER, THE DEFECT IS CONFIRMED. AS AN ACTION PLAN A SCAR WAS RAISED TO THE SUPPLIER OF THE MATERIAL. THE SUPPLIER HAS MADE THE FOLLOWING CORRECTION: ¿REFERENCE QUALITY PROBLEM OF ¿CENTER LOCKING¿ FOUND IN BD VENFLON ¿ II (8000000) AND OUR TEAM TAKEN THIS SERIOUSLY. OUR TEAM THOROUGHLY CHECKED CUTTING DIE/TOOL FOR DIMENSIONS WITH THE KLD SHARED TO US WITH GRAPHICS/ARTWORK AND FOUND THE DIE/TOOL CORRECT FOR DIMENSIONS. ALSO CARTON SAMPLES CHECKED & FORMED PHYSICALLY AND FOUND CORNER LOCKS & CENTER LOCK OK.¿ COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON I 18GA 1.2 MM X 45MM PACKAGING HAD POOR PERFORATION. THIS OCCURRED ON 250 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FEEDBACK FROM CUSTOMER (SUB STOCKIEST) REG VENFLON I PACKING IS NOT GOOD (NEW PACKING). BOTH THE SIDES OPEN, NOT CLOSED BOTH THE SIDES WITH TAPE OR PLASTER. CANNULAS ARE DROPPING FROM THE CARTON ON PICK UP FROM THE CASE BOX, VERY INCONVENIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081965 VENFLON I 18GA 1.2 MM X 45MM CATHETER FOZ 1101912

    Patients

    Seq Age Sex Outcome Treatment
    1