BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS

    MDR report key: 7222447 · Received January 26, 2018

    Report

    Report Number
    8041187-2018-00007
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    December 29, 2017
    Report Date
    March 7, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K984059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DEVICE HISTORY RECORD OF PACKAGED NEEDLE BATCH 6336348, CATALOGUE NUMBER 382412 AND ITS ASSEMBLED NEEDLE BATCHES 6323142 AND 6323139, PART NUMBER 8365076 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. DEVICE HISTORY RECORD OF CATHETER ADAPTER BATCHES 6327023, 6298270, AND 6298269, CATALOGUE NUMBER 8003235 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. THE PREVENTIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HISTORY RECORDS WERE REVIEWED. NO ABNORMALITY WAS OBSERVED ON THE RECORDS. TWO PHOTOS WERE RETURNED FOR INVESTIGATION. DAMAGED CATHETER ADAPTER WAS OBSERVED IN THE RETURNED PHOTOS. ONE ACTUAL SAMPLE WITHOUT PACKAGING AND CANNULA ASSEMBLY WAS RETURNED FOR INVESTIGATION. OUR QUALITY ENGINEER INSPECTED THE RETURNED UNIT AND CONFIRMED THE REPORTED OBSERVATION. THE CRACKED ADAPTER WAS OBSERVED ON THE RETURNED SAMPLE WHICH CAUSED THE LEAKAGE. THE PROBABLE ROOT CAUSE OF THE NONCONFORMANCE COULD BE DUE TO MACHINE MISALIGNMENT DURING THE PICK AND PLACE OF THE ADAPTER. HOWEVER, THERE IS A CHECK ON THE ALIGNMENT OF THE PICK AND PLACE STATION DURING MACHINE START-UP. A COMMUNICATION WILL BE CONDUCTED TO ALL MANUFACTURING PERSONNEL TO PERFORM PROPER MACHINE START UP PROCEDURE AT THE START OF EVERY SHIFT. NO OTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 DURING USE OF THE BD ANGIOCATH¿ PLUS WITHIN ONE HOUR AFTER INITIATING USE, THE DRUG LEAKED FROM THE CONNECTION. CUSTOMER CONFIRMED THERE WAS A CRACK ON THE CATHETER ADAPTER. LEAKED DRUG IS A MIXTURE OF ADETPHOS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65078 BD ANGIOCATH¿ PLUS INTRAVENOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6336348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other