BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13081282 · Received December 23, 2021

    Report

    Report Number
    3014704491-2021-00386
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 25, 2021
    Report Date
    December 28, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN CORRECTED: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DAMAGED UNIT PACKAGING WITH A BREACH IN STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRN WAS CHECKED BEFORE THE OPERATION, AND IT WAS FOUND THAT THE OUTER PACKAGE WAS DAMAGED AND AIR LEAKAGE WAS FOUND. THE PRN WITHOUT AIR LEAKAGE WAS IMMEDIATELY REPLACED WITH A NEW DEVICE. F11: IMDRF ANNEX A CODE: A020503. H6: INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111432. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. THE PATIENT'S INDWELLING NEEDLE ON DAY 3 INDICATED THAT THERE WAS NO ABNORMALITY IN THE INITIAL USE OF THE PRODUCT. NO DEFECTIVE PICTURE OR SAMPLE RETURNED, THE BROKEN AND BENT STATE OF THE INTERFACE OF THE PRN OF THE INDWELLING NEEDLE CANNOT BE CONFIRMED. DUE TO THE UNCLEAR DESCRIPTION, WHETHER THE PACKAGE DAMAGE AND AIR LEAKAGE REFERS TO THE PACKAGE OF THE INDWELLING NEEDLE OR THE REPLACEMENT OF PRN CAN NOT BE CONFIRMED. DHR REVIEW OF THE INDWELLING NEEDLE (LOT#1111432): THE COMPLAINT GAUGE IS 18G, ASSEMBLY AT AUTO LINE 4 IN (B)(6) 2021,PACKAGING AT R240 PACKING MACHINE IN (B)(6) 2021, LOT QUANTITY IS 186K; REVIEWED THE IN PROCESS TEST AND OUTGOING TEST REPORT FOR THIS LOT PRODUCT, ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS, NO ABNORMALITY FOUND; REVIEWED THE PRODUCTION RECORD AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, AND NO ABNORMALITY, DEVIATION OR REWORK ACTIVITIES WERE FOUND; THE PRN LOT NUMBER FOR THIS PRODUCT IS LOT #1078627/1113824, REVIEWED THE INCOMING INSPECTION RESULT, NO ABNORMALITY FOUND FOR IT. CHECKED THE PACKAGE AND PRN INTERFACE OF THE RETAINED SAMPLES OF THIS BATCH OF INDWELLING NEEDLE. NO ABNORMALITY WAS FOUND. NO ABNORMALITY FOUND ON PROCESS. AS NO DEFECTIVE SAMPLE WAS RETURNED, AND THE USAGE DURING THE PERIOD IS UNKNOWN, THE ROOT CAUSE OF THE BROKEN AND BENT INTERFACE OF THE PRN OF THE INDWELLING NEEDLE CANNOT BE DETERMINED. IN ADDITION, IT IS NOT CLEAR WHETHER THE PACKAGE DAMAGE AND AIR LEAKAGE REFERS TO THE PACKAGE OF INDWELLING NEEDLE OR THE REPLACEMENT OF PRN, AND ITS ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRN WAS CHECKED BEFORE THE OPERATION, AND IT WAS FOUND THAT THE OUTER PACKAGE WAS DAMAGED AND AIR LEAKAGE WAS FOUND. THE PRN WITHOUT AIR LEAKAGE WAS IMMEDIATELY REPLACED WITH A NEW DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DAMAGED UNIT PACKAGING WITH A BREACH IN STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRN WAS CHECKED BEFORE THE OPERATION, AND IT WAS FOUND THAT THE OUTER PACKAGE WAS DAMAGED AND AIR LEAKAGE WAS FOUND. THE PRN WITHOUT AIR LEAKAGE WAS IMMEDIATELY REPLACED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970525 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1111432

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown