BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L

    MDR report key: 8945591 · Received August 29, 2019

    Report

    Report Number
    8041187-2019-00687
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    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

    H.6. INVESTIGATION: FIVE PHOTOS AND 1 ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION OF THIS COMPLAINT. A LONG LOOSE FOREIGN MATTER WAS OBSERVED TO BE SEAL WITHIN THE UNIT PACKAGING. A STRAND OF THE FM WAS OBSERVED TO BE SEAL ACROSS THE SEALING OF THE UNIT PACKAGING. ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE PHOTOS RETURNED. SAMPLE WAS NOT DECONTAMINATED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE RETURNED SAMPLE WAS INSPECTED AND THE PRESENCE OF FOREIGN MATTER WAS CONFIRMED. THE LOOSE FM WAS SENT OUT TO EXTERNAL LABORATORY FOR FTIR TO ANALYZE AND IDENTIFY THE COMPOSITION OF THE FM. BASED ON THE LAB RESULT, THE FM MATCHES REASONABLY WITH THAT OF POLY(ETHYLENE TEREPHTHALATE). POLY(ETHYLENE TEREPHTHALATE) IS A THERMOPLASTIC POLYMER RESIN OF THE POLYESTER FAMILY AND IS USED IN SYNTHETIC FIBRES, CONTAINERS, THERMOFORMING IN MANUFACTURING, ENGINEERING RESINS AND PACKAGING MATERIALS. IT WAS IDENTIFIED THAT THE BOTTOM WEB MATERIAL USED FOR UNIT PACK IS APET PLASTIC, WHICH IS ALSO KNOWN AS POLY(ETHYLENE TEREPHTHALATE). THE PROBABLE ROOT CAUSE OF THE FM FOUND IN THE UNIT PACK COULD BE FROM THE UNIT PACKAGING PROCESS OR FROM THE BOTTOM WEB MATERIAL. THE UNIT PACKAGING PROCESS CONSIST OF FEEDING OF BOTTOM WEB MATERIAL, FOLLOWED BY FORMING OF UNIT BLISTER, THEN PLACEMENT OF PRODUCT INTO THE UNIT BLISTER. THE TOP WEB IS PRINTED BEFORE FEEDING TO SEAL WITH THE BOTTOM WEB. BASED ON CONDITION OF THE PET FM, THE FM IS LOOSE AND THEREFORE COULD BE INTRODUCED TO THE UNIT BLISTER AFTER THE UNIT BLISTER FORMING STATION. THIS IS BECAUSE THE PET FM IS LOOSE AND NOT FORM OR STICK TOGETHER WITH THE UNIT BLISTER. IF THE PET FM WAS INTRODUCED BEFORE THE FORMING STATION, IT WOULD BE BONDED TOGETHER WITH THE UNIT BLISTER DUE TO HEAT APPLIED. BASED ON THE LOCATION OF THE PET FM, THE FM IS ON THE TOP SURFACE OF THE PRODUCT. THIS SUGGEST THAT THE PET FM COULD HAD DROP INTO THE UNIT BLISTER BEFORE THE PRODUCT PLACEMENT. THIS IS BECAUSE, THE PRODUCT IS PLACE INTO THE UNIT BLISTER IN DOWNWARDS DIRECTION AND THE PET FM IS AT THE BOTTOM WHEN PRODUCT IS PLACE INTO THE UNIT BLISTER. THEREFORE, THE PET FM COULD BE INTRODUCED AFTER THE FORMING STATION AND BEFORE PRODUCT PLACEMENT INTO THE UNIT BLISTER. THE MANUFACTURING PROCESS AREA WAS REVIEWED. MACHINE IS COVERED FROM BOTTOM WEB LOADING, UNIT BLISTER FORMING AREA, UP TO PRODUCT PLACEMENT. THERE IS NO POSSIBILITY OF LOOSE PET FM BEING INTRODUCED IN BETWEEN. THE LOOSE PET FM COULD BE COMING TOGETHER IN THE BOTTOM WEB MATERIAL ROLL. DURING VENDOR'S PRODUCTION PROCESS OF BOTTOM WEB, THE BOTTOM WEB COULD ATTRACT RANDOM LOOSE DEBRIS OF BOTTOM WEB MATERIAL FROM CUTTING AND RESULTED IT TO BE SPOOL INTO THE MATERIAL ROLL. WHEN THE MATERIAL ROLL WAS USED BY MANUFACTURING, THE LOOSE DEBRIS COULD BE STICKING TO THE NON-FORMING PUNCH AREA ON THE BOTTOM WEB. THE LOOSE PET FM EVENTUALLY DROP INTO THE BLISTER AFTER FORMING AND GET PACK TOGETHER WITH THE PRODUCT. THIS IS THE FIRST RARE CASE OF SUCH COMPLAINT. THE ACTUAL ROOT CAUSE CANNOT BE CONFIRMED. COMPLAINT TREND WOULD BE MONITORED. A GMP AWARENESS TRAINING HAS BEEN PERFORMED FOR ALL ASSOCIATES WORKING IN VENFLON PRODUCTION LINE AND THIS COMPLAINT BATCH WAS PRODUCED BEFORE THE TRAINING DATES. THE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT TREND WOULD BE MONITORED. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE A FIBROUS FOREIGN MATTER WAS DISCOVERED IN PACKAGING AND THROUGH SEAL OF PACKAGE WITH A BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BECOME AWARE OF A 'BD VENFLON PRO SAFETY' DEVICE THAT WAS WITHIN MY DEPARTMENT. THIS PARTICULAR DEVICE IS CONTAMINATED WITHIN THE STERILE PACKAGING BY WHAT APPEARS TO BE A FIBROUS STRANDED SUBSTANCE. STRANDS OF THIS EMERGE THROUGH THE SEALING OF THE PACKAGING ACROSS THE SEAL THOUGH THE ITEM IS STILL IN A SEALED CONDITION. I AM WRITING TO INFORM YOU OF THIS ISSUE AND ASK FOR ANY ADVICE ON HOW TO PROCEED AS I BELIEVE SUCH A CONTAMINATED PRODUCT TO REPRESENT A POTENTIAL INFECTION RISK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PRIOR TO USE A FIBROUS FOREIGN MATTER WAS DISCOVERED IN PACKAGING AND THROUGH SEAL OF PACKAGE WITH A BD VENFLON PRO SAFETY 20GA 1.1 MM OD 32 MML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BECOME AWARE OF A 'BD VENFLON PRO SAFETY' DEVICE THAT WAS WITHIN MY DEPARTMENT. THIS PARTICULAR DEVICE IS CONTAMINATED WITHIN THE STERILE PACKAGING BY WHAT APPEARS TO BE A FIBROUS STRANDED SUBSTANCE. STRANDS OF THIS EMERGE THROUGH THE SEALING OF THE PACKAGING ACROSS THE SEAL THOUGH THE ITEM IS STILL IN A SEALED CONDITION. I AM WRITING TO INFORM YOU OF THIS ISSUE AND ASK FOR ANY ADVICE ON HOW TO PROCEED AS I BELIEVE SUCH A CONTAMINATED PRODUCT TO REPRESENT A POTENTIAL INFECTION RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741759 BD VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L SAFETY SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9074820

    Patients

    Seq Age Sex Outcome Treatment
    1 Other