BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET AN120 W/O BP

    MDR report key: 7276909 · Received February 16, 2018

    Report

    Report Number
    2243072-2018-00035
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 24, 2018
    Report Date
    January 29, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMG
    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 · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD (B)(6) HAS BEEN LISTED AND THE (B)(6) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. THE SPIKE OF THE COMPLAINT SAMPLE WAS BROKEN. SBDM ANALYSED IT AND NOTICED THE BROKEN TIP WAS INSIDE THE FLUID. SPIKE TIP BREAK TEST - SBDM TESTED 10 SAMPLES TO SEE HOW MUCH WEIGHT WAS NEEDED TO ADD ON FOR THE SPIKE TO BREAK. THE RESULT SHOWS THE SPIKE TIP BREAK IN THE AVERAGE OF 12.69 KGF. SPIKE INSERTION TEST - SBDM TOOK A SPIKE COHERENCE TEST WITH SIMILAR RUBBER PORTS WITH FLUID ENCLOSED. THE RESULTS SHOW THE SPIKE PASSE THROUGH THE RUBBER PORT WITH AVERAGE STRENGTH OF 6.91 KGF. CONCLUSION FROM THE 2 TEST CONDUCTED IS THAT THE MAXIMUM FROM SPIKE INSERTION TEST (7.78 KGF) IS SMALLER THAN THE MINIMUM RESULT FROM SPIKE TIP BREAK TEST (9.39 KGF) HOUSE SAMPLES - SBDM CHECKED HOUSE SAMPLES FOR LOT NO 2712112, 2712151, 2712161, 2801021 AND 2801111, MANUFACTURED IN DEC 2017 AND JAN 2018 WHICH ARE ASSUME THE LOT NO. OF COMPLAINT CASE. 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. ROOT CAUSE: FROM INVESTIGATION, IT SHOWS THE SPIKE TIP WAS NOT BROKEN WHEN SPIKE TIP IS NORMALLY INSERTED INTO THE RUBBER PORT. THE LIKELY CAUSE IS DUE TO THE WINTER SEASON, THE HARDNESS OF THE RUBBER IS STRONGER THAN USUAL CAUSED BY LOW TEMPERATURE. THERE IS A POSSIBILITY THE SPIKE TIP CAN BE BROKEN WHEN INSERTING INTO THE HARDEN RUBBER PORT. CORRECTIVE ACTION: 1. HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET ASSEMBLY & MOLDING LINE WORKERS AND QUALITY INSPECTORS. 2. ARE STRENGTHENING OVERALL IV SET MANUFACTURING PROCESS AND KEEPING MONITORING OF IT TO PREVENT THE RECURRENCE OF THE SAME COMPLAINT CASE. 3. WILL FULLY INSPECT SPIKE IN THE INJECTION LINE AND CHECK SPIKE MOLD. THEREFORE, WE WILL REVIEW SPIKE MOLD DESIGN TO IMPROVE THE SPIKE QUALITY. CONCLUSION: 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 MORE HARDEN DURING LOW TEMPERATURE, THERE IS A POSSIBILITY THAT SPIKE TIP MAY BE BROKEN WHEN INSERTING INTO THE HARDEN RUBBER PORT. NO CAPA IS REQUIRED;HOWEVER, SUPPLIER CAPA-(B)(4) WAS INITIALED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPIKE OF A BD¿ IV SET AN120 W/O BP WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122335 BD¿ IV SET AN120 W/O BP IV SET FMG BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other