BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 8600423 · Received May 10, 2019

    Report

    Report Number
    2243072-2019-00898
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 24, 2019
    Report Date
    July 1, 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

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2901081. 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 THE ANOTHER RECEIVED COMPLAINT SAMPLE OF 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.: 13, MINIMUM LENGTH: 8.22. MAXIMUM LENGTH: 8.34) & HOUSE SAMPLE, CONCLUSION WAS THERE SEEMS TO BE ECCENTRICITY ISSUE IN THE ROLLER. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM LOTS 2901021, 2901081 AND 2901212, 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 LOT 2901081, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, THERE ARE SIMILAR ISSUE FROM OTHER CUSTOMERS. CORRECTIVE ACTIONS: 1. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET ASSEMBLY LINE WORKERS. 2. SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR INJECTION LINE PROCESS INSPECTOR AND FOCUS ON ROLLER ECCENTRICITY UNTIL WE WOULD ENSURE THIS ISSUE WOULD BE SOLVED. 3. SBDM IMPLEMENTED TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR ROLLER INJECTION MOLDING & IV SET MANUFACTURING PROCESS. 4. SBDM CONDUCTED FINE-TUNE OF ROLLER MOLDING PLATE LEVEL. 5. SBDM MEASURED OF LENGTH FROM CENTER TO EDGE OF ROLLER AFTER MAINTAINED THE ROLLER MOLD AND THE MAXIMUM GAP WAS 0.07 AND THE AVERAGE GAP WAS 0.02, AND ALSO CONDUCT LEAK TEST BY MAINTAINED ROLLER COMPONENTS, THERE WAS NO LEAKAGE EVEN 1 DROP. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM. 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. SBDM ALSO CONDUCTED FURTHER TEST OF TUBE INNER & OUTER MEASUREMENT AND CHECK ECCENTRICITY OF ROLLER COMPONENT. THIS IS BECAUSE EVEN THERE WAS NO LEAKAGE IN THIS COMPLAINT SAMPLE, SBDM FOUND LEAKAGE ON SOME OF THE RECEIVED SAMPLE IN OTHER CASE, PRODUCT: IV SET AN120 W/O BP. SBDM 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 THE OTHER CASE. 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. SBDM HAS INHOUSE CAPA-19-037 IN PLACE TO MONITOR DEFECT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV SET AN120 W/O BP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CLAMPING THE TUBE, DRUG WAS INFUSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV SET AN120 W/O BP EXPERIENCED LEAKAGE. 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
    391673 IV SET AN120 W/O BP IV ADMINISTRATION SET FPA BECTON DICKINSON 2901081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other