BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 8745076 · Received June 28, 2019

    Report

    Report Number
    2243072-2019-01288
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 11, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 2 SAMPLES 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 SAMPLES, 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 THE ANOTHER RECEIVED COMPLAINT SAMPLE WHICH WAS THE SAME COMPLAINT ISSUE. 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: 8.23) & HOUSE SAMPLE, CONCLUSION WAS THERE SEEMS TO BE ECCENTRICITY ISSUE IN THE ROLLER. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM POTENTIAL LOTS 2902252, 2903142 AND 2903191, NO ABNORMALITY WAS OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR POTENTIAL LOTS 2902252, 2903142 & 2903191, NO ABNORMALITY WAS OBSERVED. MEASUREMENT OF LENGTH FROM CENTER TO EDGE OF ROLLER (SPEC 8.3MM±0.1): SBDM INSPECTED 10PCS HOUSE SAMPLE OF LOT 2903142, ALL COMPONENTS ARE IN SPEC ON THE HOUSE SAMPLES. 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 A LOOSE CLAMPS OCCURRED DURING USE WITH IV SETS AN120 W/O BP . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ROLLER CLAMP OF AN120 IV SET IS UNTIED DURING INFUSION THERAPY." 5 OCCURRENCES WERE REPORTED BUT THE DATE/TIME AND PATIENT INFORMATION WAS NOT GIVEN.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR: 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 THAT A LOOSE CLAMPS OCCURRED DURING USE WITH IV SETS AN120 W/O BP . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ROLLER CLAMP OF AN120 IV SET IS UNTIED DURING INFUSION THERAPY." 5 OCCURRENCES WERE REPORTED BUT THE DATE/TIME AND PATIENT INFORMATION WAS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536401 IV SET AN120 W/O BP INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other