BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ PLUS

    MDR report key: 7017665 · Received November 10, 2017

    Report

    Report Number
    8041187-2017-00162
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 18, 2017
    Report Date
    December 7, 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.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: SAMPLE INVESTIGATION ¿ A TOTAL OF 206 SAMPLES WERE RETURNED IN DIFFERENT PACKAGING. BROWN EMBEDDED FM AND LOOSE WHITE POWDERY FM WAS FOUND IN THE NEEDLE COVER. EMBEDDED FM AND WHITE FM WAS FOUND. ALSO, TWO NON-BD PRODUCTS WERE RETURNED IN OPENED PACKAGING THAT WERE STUCK ON THE SHELF CARTON. THE BREAKDOWN OF THE RESULTS IS INDICATED BELOW: NO OF SAMPLES: 90, OPEN / UNOPENED: NOT IN ANY PRIMARY PACKAGING, NO OF FM FOUND: WHITE FM = 5 PCS; EMBEDDED FM = 1 PC; 50, IN OPENED PRIMARY PACKAGING, WHITE FM = 2 PCS; EMBEDDED FM = 2 PCS; 50, IN OPENED PRIMARY PACKAGING, EMBEDDED FM = 1 PC; 14, IN OPENED PRIMARY PACKAGING, NO FM FOUND. PHOTO INVESTIGATION ¿ N/A. DHR - A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7111357. INVESTIGATION CONCLUSION: BROWN EMBEDDED, WHITE FM AND EMBEDDED FM WAS FOUND ON THE RETURNED SAMPLES. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED CONFIRMED. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. PRODUCT WAS NOT WITHIN SPECIFICATION. A SCAR (B)(4) HAS BEEN ISSUED TO THE TOP WEB SUPPLIER. A SCAR (B)(4) HAS BEEN ISSUED TO THE NEEDLE COVER SUPPLIER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND ON THE CATHETER OF A BD ANGIOCATH¿ PLUS PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802270 BD ANGIOCATH¿ PLUS INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7111357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other