BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET

    MDR report key: 8755951 · Received July 2, 2019

    Report

    Report Number
    2243072-2019-01320
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 11, 2019
    Report Date
    September 13, 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: INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2901182. SBDM CONDUCTED CLAMPING TEST FOR NORMAL USING CONDITION AND AIR PRESSURE TEST FOR THE COMPLAINT SAMPLE. CLAMPING TEST UNDER NORMAL USING CONDITION: SBDM CONDUCT CLAMPING TEST UNDER NORMAL USING CONDITION FOR THE COMPLAINT SAMPLES, IT WAS OBSERVED 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 SAMPLE, IT WAS OBSERVED THE CLAMP COULD HOLD AIR AND THERE WAS NO AIR BUBBLE LEAKAGE. TUBE INNER & OUTER DIAMETER MEASUREMENT (MEASURED BY PROFILE PROJECTOR): SBDM MEASURED THE INNER & OUTER DIAMETER OF TUBE RECEIVED COMPLAINT SAMPLE AND HOUSE SAMPLES, THE DIAMETER SIZE WAS WITHIN THE SPEC SIZE. USING VERNIER CALIPER, SBDM MEASURED THE LENGTH FROM CENTER TO EDGE OF ROLLER FOR THE RECEIVED COMPLAINT SAMPLE, CONCLUSION WAS THE LENGTH WAS DIFFERENT WHEN THE ROLLER IS IN DIFFERENT LOCATION. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM LOTS 2901151, 2901182 AND 2902112, NO ABNORMALITY OBSERVED. MEASUREMENT OF LENGTH FROM CENTER TO EDGE OF ROLLER (SPEC 8.3MM±0.1): SBDM INSPECTED 10PCS HOUSE SAMPLE OF LOT 2901182, ALL COMPONENTS ARE IN SPEC ON THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2901182, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, THERE WAS SIMILAR COMPLAINT FROM OTHER CUSTOMERS. ROOT CAUSE: THE COMPLAINT SAMPLE RECEIVED WAS AFTER A FULL TRIP, THERE SHOULD BE NO AIR IN THE TUBE, BUT CONTINUOUS AIR DROPLETS ARE FOUND WHILE PREPARING. 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 CONDUCTED FURTHER INVESTIGATION AND CHECK FOR ECCENTRICITY IN THE ROLLER COMPONENT. IN CONCLUSION, SBDM ASSUMED THAT WHEN NARROW LOCATION OF THE ROLLER MET WITH NARROW TUBE, WHICH LIKELY WAS STRETCHED OUT BY TEMPERATURE OR HUMAN FORCE, THE MEDICINE LEAKAGE MIGHT OCCURRED INFREQUENTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ IV SET THERE WAS AIR IN TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER A FULL TRIP, THERE SHOULD BE NO AIR IN THE TUBE BUT CONTINUOUS AIR DROPLETS ARE FOUND WHILE PREPARING. THEY THINK IT'S A ROLLER-CLAMP PROBLEM.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ IV SET THERE WAS AIR IN TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER A FULL TRIP, THERE SHOULD BE NO AIR IN THE TUBE BUT CONTINUOUS AIR DROPLETS ARE FOUND WHILE PREPARING. THEY THINK IT'S A ROLLER-CLAMP PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549641 BD¿ IV SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2901182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other