BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS

    MDR report key: 7017664 · Received November 10, 2017

    Report

    Report Number
    8041187-2017-00165
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 18, 2017
    Report Date
    December 11, 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

    INVESTIGATION SUMMARY: A TOTAL OF 206 SAMPLES WERE RETURNED IN DIFFERENT PACKAGING. VISUAL INSPECTION WAS PERFORMED ON ALL THE SAMPLES. THE SUMMARY OF THE RESULTS ARE STATED AS BELOW. PACKAGE LABEL NO OF SAMPLES OPEN / UNOPENED NO OF FM FOUND A 90 NOT IN ANY PRIMARY PACKAGING WHITE FM = 5 PCS EMBEDDED FM = 1 PC B 50 IN OPENED PRIMARY PACKAGING WHITE FM = 2 PCS EMBEDDED FM = 2 PCS C 50 IN OPENED PRIMARY PACKAGING EMBEDDED FM = 1 PC D 14 IN OPENED PRIMARY PACKAGING NO FM FOUND. NOTE THAT 2 NON-BD PRODUCTS WERE RETURNED IN OPENED PACKAGING THAT WERE STICK ON THE SHELF CARTON. BROWN EMBEDDED FM WAS FOUND IN THE NEEDLE COVER. LOOSE WHITE POWDERY FM WAS FOUND ON THE NEEDLE COVER. FIGURE 3.0: EMBEDDED FM AND WHITE FM FOUND. INVESTIGATION CONCLUSION: WHITE FM AND EMBEDDED FM WAS FOUND. ROOT CAUSE DESCRIPTION: LOOSE WHITE POWDERY FM WAS FOUND. THE WHITE POWDERY FM IS MORE LIKELY FROM THE TOP WEB MATERIAL. A (B)(4) HAS BEEN ISSUED TO THE TOP WEB SUPPLIER. BROWN EMBEDDED FM WAS FOUND IN THE NEEDLE COVER. A (B)(4) HAS BEEN ISSUED TO THE NEEDLE COVER SUPPLIER FOR FURTHER INVESTIGATION. DHR- DEVICE HISTORY RECORD OF PACKAGED NEEDLE(PN) BATCH 7111357, CATALOG NUMBER 382412 AND ITS ASSEMBLED NEEDLE(AN) BATCHES 7111413, 7111395 AND 7111412, PART NUMBER 8365076 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.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 THAT A BD ANGIOCATH¿ PLUS WAS FOUND BEFORE USE WITH FOREIGN PARTICLES ON CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802550 BD ANGIOCATH¿ PLUS INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7111357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other