BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM

    MDR report key: 7819908 · Received August 27, 2018

    Report

    Report Number
    3006948883-2018-00160
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 7, 2018
    Report Date
    October 26, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE ACTUAL SAMPLE WAS PROVIDED FOR THIS COMPLAINT. THE ACTUAL SAMPLE WAS EVALUATED AND DID SHOW THE REPORTED FAILURE MODE WHICH CONFIRMED THIS COMPLAINT. AS PER REQUEST, FTIR ANALYSIS WAS COMPLETED ON THE MATERIAL OBSERVED ON THE NEEDLE. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. DHR FOR LOT # 7325226: ASSEMBLY DATE OF THIS LOT IS DEC. 2017. QTY IS 136K IN AUTO LINE #1. DHR FOR LOT # 7234053: ASSEMBLY DATE OF THIS LOT IS SEP. 2017. QTY IS 136K IN AUTO LINE #2. THE BATCH RECORDS FOR LOT#7325226 AND 7234053 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND DURING THE MANUFACTURING PROCESS. CHECKED THE CATHETER SURFACE OF THE RETURNED SAMPLE, THERE IS A TRANSPARENT VISCOUS SUBSTANCE ON THE OUTER SURFACE OF THE CATHETER TOP. IT CAN BE CONFIRMED AS A PRECIPITATE OF DC360 LUBRICATING FLUID WHICH IS SILICONE. THIS IS USED BECAUSE IT ADHERES TO THE SURFACE OF THE CATHETER SO THAT THE CATHETER CAN ENTER THE VEIN SMOOTHLY. THIS INGREDIENT IS A NON-TOXIC AND HARMLESS EXCIPIENT SPECIFIED IN THE REGISTRATION DOCUMENT. CORRECTIVE ACTION INCLUDES MONTHLY MAINTENANCE TO CLEAN THE LUBRICATION TANK, AND THE CLEANING CYCLE OF THE LUBRICATION TANK WILL BE EFFECTIVELY EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, THE NURSE FOUND SOMETHING LIKE BARB AND BUMP AT THE CATHETER AFTER REMOVING THE CAP. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7325226, MEDICAL DEVICE EXPIRATION DATE: 2020-12-28 , DEVICE MANUFACTURE DATE: 2017-11-21 . MEDICAL DEVICE LOT #: 7234053, MEDICAL DEVICE EXPIRATION DATE: 2020-09-19, DEVICE MANUFACTURE DATE: 2017-08-22. 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 BEFORE USE OF THE BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM, THE NURSE FOUND SOMETHING LIKE BARB AND BUMP AT THE CATHETER AFTER REMOVING THE CAP. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662337 BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM CATHETER SOLUTIONS FOZ BD (SUZHOU) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other