BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE

    MDR report key: 6774533 · Received August 8, 2017

    Report

    Report Number
    1911916-2017-00177
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 13, 2017
    Report Date
    October 24, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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. UDI #: (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: FTIR SCAN RESULT WAS A 54% MATCH WITH SUCROSE IN KBR. THAT IS NOT SOMETHING WE USE IN ASSEMBLY OR PACKAGING. CONCLUSION: UNABLE TO DETERMINE. WE DON¿T USE ANYTHING THAT WOULD LEAVE RED. FM DURING THE ASSEMBLY OR PACKAGING PROCESS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE INCORRECT AWARENESS DATE WAS REPORTED AS 8/7/2017 IN THE INITIAL MDR. THE CORRECT AWARENESS DATE WAS 7/13/2017. DEVICE EVALUATION: DHR REVIEW: NINE VISUAL INSPECTIONS WERE PERFORMED ON 540 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED TWICE DURING THE PACKAGING OF THIS BATCH. ASSEMBLY BATCH 5240596 HAD 115 VISUAL INSPECTIONS PERFORMED ON 5,750 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 15 TIMES DURING THE PRODUCTION OF THIS BATCH. ASSEMBLY BATCH 5119836 HAD 143 VISUAL INSPECTIONS PERFORMED ON 7,150 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 20 TIMES DURING THE PRODUCTION OF THIS BATCH. ALL CLEANING WAS PERFORMED PER THE REQUIREMENTS OF (B)(4). INVESTIGATION RESULTS: ONE SAMPLE WAS RETURNED. THERE APPEARS TO BE A PIECE OF RED FM ON THE FILTER THAT BLED INTO THE FILTER WHEN USED. POSSIBLE ROOT CAUSE: UNABLE TO DETERMINE. WE DON¿T USE ANYTHING THAT WOULD LEAVE RED FM DURING THE ASSEMBLY OR PACKAGING PROCESS. IF CORRECTIVE/PREVENTATIVE ACTION NOT REQUIRED, PROVIDE RATIONALE: THIS APPEARS TO BE AN ISOLATED INCIDENT. NO CAPA WILL BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN USED A 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE TO PREPARE AND PRIME A DOSE OF AN UNSPECIFIED MEDICATION AND FOREIGN MATTER WAS NOTICED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553413 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 5240603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other