BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6821398 · Received August 25, 2017

    Report

    Report Number
    1911916-2017-00198
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 6, 2017
    Report Date
    September 28, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4181639, MEDICAL DEVICE EXPIRATION DATE: 2019-08-31, DEVICE MANUFACTURE DATE: 2014-11-11. MEDICAL DEVICE LOT #: 4181641, MEDICAL DEVICE EXPIRATION DATE: 2019-09-30, DEVICE MANUFACTURE DATE: 2014-11-11. MEDICAL DEVICE LOT #: 4181640, MEDICAL DEVICE EXPIRATION DATE: 2019-09-30, DEVICE MANUFACTURE DATE: 2014-11-11. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INVESTIGATION SUMMARY QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THESE BATCHES, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. DHR REVIEW: BATCH 4181639 ¿ ASSEMBLY BATCH 4181680 HAD 77 VISUAL INSPECTIONS PERFORMED ON 4,000 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED NINE TIMES DURING THE PRODUCTION OF THIS BATCH. ASSEMBLY BATCH 4218694 HAD 51 VISUAL INSPECTIONS PERFORMED ON 2,700 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED SIX TIMES DURING THE PRODUCTION OF THIS BATCH. BATCH 4181640 ¿ ASSEMBLY BATCH 4218694 HAD 51 VISUAL INSPECTIONS PERFORMED ON 2,700 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED SIX TIMES DURING THE PRODUCTION OF THIS BATCH. BATCH 4181641 ¿ ASSEMBLY BATCH 4218694 HAD 51 VISUAL INSPECTIONS PERFORMED ON 2,700 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED SIX TIMES DURING THE PRODUCTION OF THIS BATCH. ALL CLEANING WAS PERFORMED PER (B)(4). INVESTIGATION CONCLUSION INVESTIGATION RESULTS: UNABLE TO COMPLETE; NO SAMPLES OR PHOTOS WERE PROVIDED. ROOT CAUSE DESCRIPTION POSSIBLE ROOT CAUSE: UNABLE TO DETERMINE WITHOUT SAMPLES OR PHOTOS. RATIONALE IF CORRECTIVE/PREVENTATIVE ACTION NOT REQUIRED, PROVIDE RATIONALE: DEFECT HAS NOT BEEN CONFIRMED. NO CAPA WILL BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PARTICLE WAS FOUND IN A 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600890 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other