BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 8484449 · Received April 4, 2019

    Report

    Report Number
    2243072-2019-00654
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 14, 2019
    Report Date
    June 24, 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

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE "POSSIBLE" LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2902223. D.4. MEDICAL DEVICE EXPIRATION DATE: 2/22/2022. H.4. DEVICE MANUFACTURE DATE: 2/23/2019. D.4. MEDICAL DEVICE LOT #: 2902252. D.4. MEDICAL DEVICE EXPIRATION DATE: 2/24/2022. H.4. DEVICE MANUFACTURE DATE: 2/25/2019. D.4. MEDICAL DEVICE LOT #: 2903142. D.4. MEDICAL DEVICE EXPIRATION DATE: 3/13/2022. H.4. DEVICE MANUFACTURE DATE: 3/14/2019. H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. VISUAL INSPECTION OF COMPLAINT SAMPLE: SBDM CONDUCTED VISUAL INSPECTION ON THE COMPLAINT SAMPLE, THERE WERE 2 HOLES IN THE BY-PASS. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS HOUSE SAMPLES FROM POTENTIAL LOT 2902223, 2902252 & 2903142, NO ABNORMALITY WAS OBSERVED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD POTENTIAL LOT 2902223, 2902252 & 2903142, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT RECORD FROM POTENTIAL LOT 2902223, 2902252 & 2903142, THERE ARE NO SAME ISSUE FROM OTHER CUSTOMER. CORRECTIVE ACTIONS: 1. SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR BY-PASS INCOMING INSPECTION PROCESS WORKERS AND QUALITY INSPECTORS. 2. SBDM ISSUED CAPA FOR THE COMPLAINT CASE TO THE BY-PASS SUPPLIER. 3. THE BY-PASS SUPPLIER HAS TRAIN LINE WORKERS AND INSPECTORS 4. THE BY-PASS SUPPLIER HAS CHANGED CUTTING TOOLS WHICH THE END POINT IS NOT SHARP. 5. SBDM WILL CONTINUE TO MONITOR I.V SET MANUFACTURING PROCESS TO SEE IF THE SAME COMPLAINT CASE OCCURS AGAIN. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. FROM VISUAL INSPECTION, SBDM NOTICED 2 HOLES ON THE BY-PASS. FROM INVESTIGATIONS, THE BY-PASS IS PURCHASED EXTERNALLY BY SBDM. SBDM ISSUED CAPA TO THE SUPPLIER TO FIND OUT THE ROOT CAUSE OF THE COMPLAINT CASE. ACCORDING TO THE SUPPLIER, THERE IS A REMOVING DEFECTIVE PRODUCT PROCESS AND THE INSPECTOR WAS SUPPOSED TO CUT DEFECTIVE PRODUCT BY CUTTING TOOL. HOWEVER, THE INSPECTOR HAD DAMAGED ON A NORMAL PRODUCT IN THIS PARTICULAR INCIDENT AND DIDN`T REMOVE DAMAGED PRODUCT. ALSO, DURING SBDM'S BY-PASS INCOMING INSPECTION, A SBDM INSPECTOR COULDN`T FIND THE DEFECTIVE PRODUCT IN THE WAREHOUSE, AND THE DEFECTIVE PIECE WAS RELEASED TO MANUFACTURING LINE, CAUSING THE DEFECT EXPERIENCE BY CUSTOMER. SBDM HAS IN HOUSE CAPA-19-017 IN PLACE TO MONITOR DEFECT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE IV SET AN120 W/O BP THERE WERE TWO HOLES ON THE BYPASS (LEAKAGE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO HOLES ON THE BYPASS (LEAKAGE).

    Additional Manufacturer Narrative · 1

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE IV SET AN120 W/O BP, THERE WERE TWO HOLES ON THE BYPASS (LEAKAGE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO HOLES ON THE BYPASS (LEAKAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274904 IV SET AN120 W/O BP INFUSION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other