BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 6829037 · Received August 29, 2017

    Report

    Report Number
    9610847-2017-00060
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    August 4, 2017
    Report Date
    December 28, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K923702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL LOT # REPORTED BY CUSTOMER WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN IDENTIFIED AS THE FOLLOWING: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6277695, MEDICAL DEVICE EXPIRATION DATE: 2020-09-30, DEVICE MANUFACTURE DATE: 2016-10-28, MEDICAL DEVICE LOT #: 5210533, MEDICAL DEVICE EXPIRATION DATE: 2015-08-06, DEVICE MANUFACTURE DATE: 2019-08-31. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    LOT #: THE CUSTOMER REPORTED LOT # 6077695. HOWEVER, THIS LOT # DOES NOT EXIST FOR THE REPORTED CAT # 383329. (B)(6). RESULTS: A SAMPLE OR PHOTO WAS NOT AVAILABLE FOR EVALUATION. WE COULD NOT CONFIRM THE ISSUE AT OUR CUSTOMER FACILITY WITH THE PROVIDED INFORMATION. DHR WAS NOT CONSULTED BECAUSE THE REPORTED LOT NUMBER IS INCORRECT. WITHOUT LOT NUMBER, WE COULD NOT REQUIRE THE CERTIFICATE OF STERILITY AND MICROBIOLOGICAL TESTS (PYROGENS). NOTE: THIS INCORRECT LOT NUMBER HAS ALREADY BEEN REPORTED, WHEN THE CUSTOMER REPORTS THE LOT NUMBER CORRECT, ONE NEW CHILD WILL OPENED FOR EVALUATION. CONCLUSION: WE COULD NOT FOUND THE EXACTLY ROOT CAUSE OF THE ISSUE SINCE NO SAMPLE OR PHOTO WAS RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: YES, SAMPLE RECEIVED. ACTUAL REPRESENTATIVE. THREE SAMPLES WERE RECEIVED FOR EVALUATION. TWO REPRESENTATIVE SAMPLES WERE RECEIVED (LOT 6277695), SAMPLE WAS REVIEWED, NO FOREIGN MATTER OR CONTAMINATION WAS FOUND IN THE CATHETER TIP OR NEEDLE TIP. ONE SAMPLE WAS RECEIVED USED (LOT 5210533) THE SAMPLE HAS A DEVICE NOT MANUFACTURED IN NOGALES AND THE CATHETER TIP SHOWS BLOOD. DHR FOR LOT NUMBER 6277695 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL 383329 WITH LOT NUMBER 6277695 WAS MANUFACTURED ON OCTOBER 25, 2016. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. DURING DHR REVIEW THE QA TECH TAKES 395 SAMPLES TO INSPECT VISUALLY, NO FOREIGN MATTER WAS FOUND IN FINAL ASSEMBLY. DURING DHR REVIEW THE QA TECH TAKES 3,250 SAMPLES TO INSPECT VISUALLY, NO DEFECT WAS FOUND IN PACKAGING. DHR FOR LOT NUMBER 5210533 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL 383329 WITH LOT NUMBER 5210533 WAS MANUFACTURED ON AUGUST 3, 2015. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. DURING DHR REVIEW THE QA TECH TAKES 290 SAMPLES TO INSPECT VISUALLY, NO FOREIGN MATTER WAS FOUND IN FINAL ASSEMBLY. DURING DHR REVIEW THE QA TECH TAKES 2,500 SAMPLES. MANUFACTURING REVIEW: NO EQUIPMENT, INSTRUMENT, PROCESS AND/OR SURFACES THAT COULD CAUSE THIS KIND OF REPORTED DEFECT IN MANUFACTURE. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE INVESTIGATION COMMENTS: AFTER EVALUATING TWO REPRESENTATIVE SAMPLE AND NOT FIND FOREIGN MATTER IN THE CATHETER TIP OR NEEDLE TIP, WE COULD NOT CONFIRM OR ASSOCIATE THE REPORTED DEFECT TO MANUFACTURING PROCESS. USED UNIT IT IS DIFFICULT TO FIND AN EXACTLY ROOT CAUSE OF THIS ISSUE; HOWEVER, THE CERTIFICATE OF STERILITY AND MICROBIOLOGICAL TESTS (PYROGENS) MEET WITH ACCEPTANCE CRITERIA FOR BOTH LOT NUMBERS 6277695 AND 5210533.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT(S) HAD SUPERFICIAL REDDENING/IRRITATION OF THE SKIN DURING USE OF THE 22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. IV¿S WERE REMOVED. SOME PATIENTS WERE REPORTED TO HAVE TAKEN LOW DOSE STEROIDS TO TREAT THE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607814 22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other