BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET SN404 W/O BP Y-CONN

    MDR report key: 8556572 · Received April 26, 2019

    Report

    Report Number
    2243072-2019-00802
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 11, 2019
    Report Date
    June 12, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2811152. 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 PIR3006021 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.: 20, MINIMUM LENGTH: 8.23. 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 2811132, 2811152 AND 2811232, 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 2811152, 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. 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 PIR3006021, 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 (PIR3006021). 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 BD¿ IV SET SN (B)(4) W/O BP Y-CONN TUBE WAS CLAMPED AND THE DRUG WAS INFUSED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CLAMPING THE TUBE, DRUG WAS INFUSED. CUSTOMER DISCARD THE PIR PRODUCT, BUT I WILL SEND TO THE SAME LOT PRODUCT FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ IV SET SN404 W/O BP Y-CONN TUBE WAS CLAMPED AND THE DRUG WAS INFUSED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CLAMPING THE TUBE, DRUG WAS INFUSED CUSTOMER DISCARD THE PIR PRODUCT, BUT I WILL SEND TO THE SAME LOT PRODUCT FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348899 BD¿ IV SET SN404 W/O BP Y-CONN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2811152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other