BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET AN120 W/O BP

    MDR report key: 7280957 · Received February 19, 2018

    Report

    Report Number
    2243072-2018-00060
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    February 2, 2018
    Report Date
    April 20, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE OF IV SET AN120 WAS RETURNED TO SBDM. THE SPIKE TIP OF THE COMPLAINT SAMPLE WAS BROKEN. SPIKE TIP BREAK TEST - SBDM TESTED 10 SAMPLES TO SEE HOW MUCH WEIGHT WAS NEEDED TO ADD ON FOR THE SPIKE TO BREAK USING IMPACT STRENGTH. THE RESULT SHOWS THE SPIKE TIP BREAK IN THE AVERAGE OF 12.08 KGF. SPIKE INSERTION TEST TO RUBBER PORT - SBDM TOOK A SPIKE INSERTION TEST TO RUBBER PORT WITH SIMILAR THICKNESS OF THE COMPLAINT SAMPLE. THE RESULTS SHOW THE SPIKE INSERT THROUGH THE RUBBER PORT WITH AVERAGE STRENGTH OF 6.22 KGF. CONCLUSION FROM THE 2 TESTS CONDUCTED IS THAT THE MAXIMUM FORCE FROM SPIKE INSERTION TEST TO RUBBER PORT (6.98 KGF) IS SMALLER THAN THE MINIMUM FORCE FROM SPIKE TIP BREAK TEST (8.14 KGF) HOUSE SAMPLES - SBDM CHECKED HOUSE SAMPLES FOR LOT NO 2709141, THERE WAS NO ABNORMALITY FOUND. DHR REVIEW - SBDM CHECKED MANUFACTURING RECORDS SUCH AS PROCESS INSPECTION REPORT, TEST REPORT, MOLDING MANUFACTURING RECORDS/INSPECTION RECORDS OF THE RECEIVED COMPLAINT SAMPLE, THERE WAS NO ABNORMALITY ON THE MANUFACTURING RECORDS. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET ASSEMBLY & MOLDING LINE WORKERS AND QUALITY INSPECTORS. SBDM STRENGTHENING OVERALL IV SET MANUFACTURING PROCESS AND WILL CONTINUE TO MONITOR TO PREVENT THE RECURRENCE OF THE SAME COMPLAINT CASE. WILL FULLY INSPECT SPIKE IN THE INJECTION LINE AND ENHANCE MAINTENANCE FOR SPIKE MOLD. (TWICE A WEEK FOR BASIC MAINTENANCE AND ONCE A MONTH FOR TOTAL MAINTENANCE) FROM (B)(6) 2017. BASED ON INVESTIGATION AND ANALYSIS ON THE COMPLAINT CASE (BROKEN SPIKE TIP), LIKELY CAUSE IS THAT SPIKE TIP IS INSERTED INTO RUBBER PORT WITH MORE STRENGTH DURING THE COLD SEASON, AND WITH THE RUBBER BEING HARDER DURING LOW TEMPERATURE, THERE IS A POSSIBILITY THAT SPIKE TIP MAY BE BROKEN WHEN INSERTING INTO THE HARDEN RUBBER PORT.

    Additional Manufacturer Narrative · 1

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED AS GREATER ASIA IS AN OEM MANUFACTURING SITE. ADDITIONALLY, THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DURING USE OF THE BD¿ IV SET AN120 W/O BP THERE WAS FOREIGN MATTER ON THE SPIKE OF THE IV CATHETER. THE IV CATHETER SPIKE HAS A BROKEN TIP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124750 BD¿ IV SET AN120 W/O BP IV CATHETER W/ TUBING FOZ BECTON DICKINSON 2709141

    Patients

    Seq Age Sex Outcome Treatment
    1 Other