BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS 22 G X 1 IN.

    MDR report key: 7010099 · Received November 8, 2017

    Report

    Report Number
    8041187-2017-00173
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 20, 2017
    Report Date
    December 18, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K950301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 1 PHOTO WAS SENT FOR INVESTIGATION. FM WAS OBSERVED IN THE RETURNED PHOTO. 1 ACTUAL SAMPLE IN OPENED PACKAGING WAS RETURNED FOR INVESTIGATION. FIGURE 1: ACTUAL SAMPLE. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. FM WAS OBSERVED ON THE CATHETER OF THE SAMPLE. FIGURE 2: FM ON CATHETER. THE FM WAS SUBJECTED TO FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TEST. THE RESULT OF THE TEST SHOWS THAT THE SPECTRUM OF THE FM HAD MATCHED WITH THE SPECTRUM OF POLYURETHANE. INVESTIGATION CONCLUSION: FM WAS OBSERVED ON THE CATHETER OF THE SAMPLE. DHR REVIEW: DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 7111352, CATALOG NUMBER 382423 AND ITS ASSEMBLED NEEDLE (AN) BATCHES 7111380 AND 7111381, PART NUMBER 8365077 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. MANUFACTURING REVIEW: THE PREVENTATIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HISTORY RECORDS WERE REVIEWED. NO ABNORMALITY WAS OBSERVED ON THE RECORDS. ROOT CAUSE DESCRIPTION: THE CATHETER IS OF POLYURETHANE MATERIAL. THE FM WAS FOUND ATTACHED TO THE CATHETER, HENCE, A CUT ON THE CATHETER OCCURRED. THE CUT COULD HAVE BEEN CAUSED BY THE CANNULA PIERCED THROUGH CATHETER. THE CANNULA PIERCED THROUGH CATHETER COULD HAVE OCCURRED DURING ASSEMBLY OF CATHETER AND CANNULA OR DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED. HOWEVER, THERE IS AN AUTOMATED VISION INSPECTION MACHINE, WHICH CAN DETECT AND REJECT PRODUCT WITH CANNULA PIERCED THROUGH CATHETER IN THE ASSEMBLY PROCESS. HENCE, THE ROOT CAUSE OF THE NONCONFORMANCE COULD NOT BE DETERMINED. THE TREND OF THIS NONCONFORMANCE WILL BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ANGIOCATH¿ PLUS 22 G X 1 IN. HAD FOREIGN MATTER IN THE TUBE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791644 BD ANGIOCATH¿ PLUS 22 G X 1 IN. ANGIOCATH PLUS CONVENTIONAL FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7111352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other