BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON I 20GA 1.0 MM X 32MM

    MDR report key: 10827161 · Received November 12, 2020

    Report

    Report Number
    2243072-2020-01811
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 17, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BECTON DICKINSON
    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

    H.6. INVESTIGATION: A PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A 1CC SAFETYGLIDE SYRINGE FROM LOT # 0118542, REGARDING ITEM # 391592 WITH THE REPORTED ISSUE THAT, ¿1000 UNITS VENFLON PRO 18 G SUPPLIED IN SEALED BOX OF VENFLON I 20 G. IT SHOULD HAVE CONTAINED VENFLON I 20 G ONLY¿. THE PHOTOGRAPH SHOWED THE EVIDENCE OF PRODUCT MIX (VENFLON PRO IN VENFLON I 20GA). CUSTOMER RETURNED SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. UPON FURTHER INVESTIGATION OF THE TWO LOT NUMBERS THAT GOT MIXED AND THEIR DHR REVIEW THE INVESTIGATING TEAM FOUND THAT BOTH THE LOT NUMBERS HAVE BEEN PRODUCED AND RELEASED FROM THE PLANT WITH A GAP OF 12 DAYS. THIS RULES OUT THE PROBABILITY OF THE PRODUCT GETTING MIXED DURING PACKAGING. THE TEAM REVIEWED THE PHOTOGRAPHS OF THE PRODUCT MIX AND FOUND THAT THE OUTSIDE CARTON HAD THE LABEL OF VENFLON I 20 GA WHILE THE SHIPPER HAD VENFLON PRO 18GA STICKER ON THE BOXES. THE DEFECT IS CONFIRMED. THE PROBABLE PRODUCT MIX HAS OCCURRED OUTSIDE THE PLANT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1000 VENFLON PRO 18 G CATHETERS WERE FOUND IN THE BOX OF VENFLON I 20GA 1.0 MM X 32MM CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1000 UNITS VENFLON PRO 18 G SUPPLIED IN SEALED BOX OF VENFLON I 20 G. IT SHOULD HAVE CONTAINED VENFLON I 20 G ONLY."

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1000 VENFLON PRO 18 G CATHETERS WERE FOUND IN THE BOX OF VENFLON I 20GA 1.0 MM X 32MM CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1000 UNITS VENFLON PRO 18 G SUPPLIED IN SEALED BOX OF VENFLON I 20 G. IT SHOULD HAVE CONTAINED VENFLON I 20 G ONLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292520 VENFLON I 20GA 1.0 MM X 32MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 0118542

    Patients

    Seq Age Sex Outcome Treatment
    1