BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO

    MDR report key: 18967442 · Received March 25, 2024

    Report

    Report Number
    2243072-2024-00435
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    September 11, 2023
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903932047
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    4 PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF VENFLON PRO 20G FROM LOT # 2101138 REGARDING ITEM #393204 WITH THE REPORTED ISSUE THAT PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE. CUSTOMER PROVIDED PHOTOGRAPH REVIEW: THE PHOTOS SHOWS THAT THE SEAL IS OPEN FROM THE LUER CAP END OF THE CATHETER. ONE PHOTO WITH 5 SAMPLES SHOWS 5-UNIT PACKS WITH SEAL OPEN, SECOND PHOTO SHOW 4 SAMPLES WITH UNIT PACK SEAL OPEN AGAIN FROM LUER CAP SIDE, THIRD AND FOURTH PHOTO SHOWS 1 SAMPLE EACH WHERE SEAL IS OPEN FROM LUER CAP SIDE OF UNIT PACK. THE DEFECT OF SEAL OPEN/DEFORMED PACKAGING/PACKAGING DAMAGE CAN BE CONFIRMED BASED ON THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER. RETENTION SAMPLE REVIEW: THE INVESTIGATION WAS CARRIED OUT ON 25 RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY INSPECTED THE SAMPLES FOR PACKAGE SEAL INTEGRITY AND NO POOR / QUESTIONABLE PACKAGE SEAL INTEGRITY WAS FOUND IN THE 25 RETENTION SAMPLES. THE DEFECT OF SEAL OPEN/DEFORMED PACKAGING/PACKAGING DAMAGE CANNOT BE CONFIRMED BASED ON THE INVESTIGATION OF THE RETENTION SAMPLES.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    MATERIAL #: 393204 BATCH#: 2101138. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND PACKED SLEEVES OPEN AT THE SEAL WHICH RENDERS THESE VENFLON NEEDLES UNSTERILE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED CUSTOMER FOUND PACKED SLEEVES OPEN AT THE SEAL WHICH RENDERS THESE VENFLON NEEDLES UNSTERILE BD (PRODUCT CODE: 393204). 2101138 (EXP DATE: 25.04.02). CUSTOMER RESPONSE FOR FOLLOW-UP: 1. PLEASE PROVIDE THE DATE OF EVENT. 09/11/2023 (COMPLAINT REPORTED TO US ON THE 12/02/2024). 2. KINDLY SHARE THE EXACT ADDRESS DETAILS TO SEND A RETURN SHIPPING LABEL. 106 16TH ROAD MIDRAND JOHANNESBURG, SOUTH AFRICA. 3. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? YES. 4. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? INDIRECTLY INVOLVE(NOT USED BY PATIENT). 5. HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? NO. 6. PLEASE CONFIRM THE NUMBER OF OCCURRENCES. 74.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON PRO PACKAGE SEAL IS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND PACKED SLEEVES OPEN AT THE SEAL WHICH RENDERS THESE VENFLON NEEDLES UNSTERILE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436058 BD VENFLON PRO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON 2101138 00382903932047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown