BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 8596350 · Received May 9, 2019

    Report

    Report Number
    2243072-2019-00889
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. CLAMPING TEST UNDER NORMAL USING CONDITION: SBDM CONDUCT CLAMPING TEST UNDER NORMAL USING CONDITION FOR THE COMPLAINT SAMPLE, THE CLAMP COULD HOLD MEDICINE AND THERE WAS NO DRUG INFUSION. CLAMPING TEST UNDER HIGH AIR PRESSURE: SBDM CONDUCT CLAMPING TEST UNDER AIR PRESSURE(0.51MPA) FOR THE COMPLAINT SAMPLES, THE CLAMP COULD HOLD AIR AND THERE WAS NO AIR BUBBLE LEAKAGE. HOWEVER, SBDM FOUND LEAKAGE IN THIS COMPLAINT SAMPLE WHEN THE ROLLER IS IN CERTAIN DIRECTION. SBDM THUS CONDUCTED FURTHER INVESTIGATION ABOUT TUBE INNER & OUTER DIAMETER MEASUREMENT AND ECCENTRICITY OF ROLLER COMPONENT FOR COMPLAINT SAMPLE AND HOUSE SAMPLE. TUBE INNER & OUTER DIAMETER MEASUREMENT: USING PROFILE PROJECTOR, SBDM MEASURED THE INNER AND OUTER DIAMETER OF TUBE FOR BOTH COMPLAINT SAMPLE AND HOUSE SAMPLE, THE DIAMETER ARE WITHIN SPECIFICATION. ROLLER ECCENTRICITY TEST (UNIT: MM): USING VERNIER CALIPER, SBDM MEASURED THE LENGTH FROM CENTER TO EDGE OF ROLLER FOR BOTH RECEIVED COMPLAINT SAMPLE (CAVITY NO.: 10, MINIMUM LENGTH: 8.21. MAXIMUM LENGTH: 8.40) & HOUSE SAMPLE, CONCLUSION WAS THERE SEEMS TO BE ECCENTRICITY ISSUE IN THE ROLLER. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM POTENTIAL LOTS 2901303, 2903142 AND 2904011, NO ABNORMALITY WAS OBSERVED. SBDM ALSO MEASURED THE ROLLER CLAMP CONCENTRICITY, ALL 30 ROLLER CLAMPS WAS WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR POTENTIAL LOTS 2901303, 2903142 AND 2904011, NO ABNORMALITY WAS OBSERVED. ROOT CAUSE: FROM INVESTIGATIONS, SBDM CONDUCTED INSPECTION OF THE COMPLAINT SAMPLE & HOUSE SAMPLES FOR LEAKAGE TEST UNDER NORMAL CONDITION AND HIGH PRESSURE. NO LEAKAGE WAS OBSERVED ON THE RECEIVED COMPLAINT SAMPLE. HOWEVER, LEAKAGE WAS OBSERVED ON THE COMPLAINT SAMPLE WHEN THE ROLLER IS IN CERTAIN DIRECTION. SBDM CONDUCTED FURTHER INVESTIGATION AND FOUND THERE WAS ECCENTRICITY IN THE ROLLER COMPONENT (THE LENGTH FROM CENTER TO EDGE OF ROLLER (MIN: 8.21MM, MAX: 8.4MM & GAP: 0.19MM) IN THIS CASE. THE TUBE OF THIS COMPLAINT CASE IS IN THE NOMINAL SIZE (INNER DIAMETER: 2.7MM & OUTER DIAMETER: 3.9MM. SBDM THEN CHECKED ROLLER LENGTH FROM CENTER TO EDGE FOR 21 DIFFERENT LOT FROM RETENTION SAMPLES (TOTAL: 210EA) AND THE MAXIMUM GAP WAS 0.19 AND AVERAGE GAP WAS 0.09. IN CONCLUSION, SBDM ASSUMED THAT WHEN NARROW LOCATION OF THE ROLLER WHICH HAS ECCENTRICITY AND THE SMALLEST SIZE OF TUBE ARE MET WHEN ROLLER CLAMP IS IN LOCKED POSITION, MEDICINE LEAKAGE MIGHT OCCURRED INFREQUENTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE IV SET AN120 W/O BP TUBE WAS CLAMPED AND DRUG WAS INFUSED, LEAKAGE OCCURRED AT THE LUER CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER CLAMPING THE TUBE, DRUG WAS INFUSED."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IV SET AN120 W/O BP TUBE WAS CLAMPED AND DRUG WAS INFUSED, LEAKAGE OCCURRED AT THE LUER CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER CLAMPING THE TUBE, DRUG WAS INFUSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387123 IV SET AN120 W/O BP INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other