BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 9354834 · Received November 21, 2019

    Report

    Report Number
    1911916-2019-01213
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 31, 2019
    Report Date
    January 7, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RECEIVED. ONE PHOTO WAS PROVIDED. ONE SAMPLE CAME WITH OPENED PACKAGING BLISTER AND IT HAS THE PLASTIC SHIELD. IT HAS WHITE EPOXY TOWARDS THE BOTTOM OF THE NEEDLE. IT IS ABOUT 1/8¿ LONG FROM THE PLASTIC HUB. THE PHOTO SHOWS THREE PRODUCTS WITH EPOXY ON THE NEEDLE. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR. THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. IN THIS CASE IT MAY HAVE HAPPENED THAT A JAM OCCURRED, AND THE EQUIPMENT DISPENSED SILICONE BEFORE THE PART WAS MOVED TO THE NEXT STATION AND IT WAS NOT DETECTED IN THE NEXT PROCESSES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE EPOXY WAS FOUND ON THE NEEDLE WITH A BD BLUNT FILL NEEDLE WITH FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS OBSERVED THAT THE ¿WHITE MATTER/PLASTIC¿ ON THE BLUNT NEEDLES DIFFER FROM HOW THEY USUALLY ARE AND SEEM TO COVER MOST OF THE PLASTIC SURFACE. THERE ARE ALSO NO CONSISTENCY BUT JUST IRREGULARITIES. NORMALLY THE WHITE PART BETWEEN THE PINKISH PLASTIC TO THE METAL SHOULD ONLY BE SEEN A LITTLE. PICTURES SHOW: ON MOST OF THE BLUNT NEEDLES THE WHITE PART GOES 1-3 MM OVER THE METAL. THIS IS ONLY ON ONE SIDE OF THE NEEDLE, SEEN IN THE PICTURE, ON THE BACKSIDE THERE IS NO IRREGULARITIES. T IN THE MIDDLE YOU SEE THE MOST IRREGULARITIES.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8047736, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-02-16, MEDICAL DEVICE LOT #: 8250854, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: 2018-09-07, MEDICAL DEVICE LOT #: 9189523, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-07-08." 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 PRIOR TO USE EPOXY WAS FOUND ON THE NEEDLE WITH A BD BLUNT FILL NEEDLE WITH FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS OBSERVED THAT THE ¿WHITE MATTER/PLASTIC¿ ON THE BLUNT NEEDLES DIFFER FROM HOW THEY USUALLY ARE AND SEEM TO COVER MOST OF THE PLASTIC SURFACE. THERE ARE ALSO NO CONSISTENCY BUT JUST IRREGULARITIES. NORMALLY THE WHITE PART BETWEEN THE PINKISH PLASTIC TO THE METAL SHOULD ONLY BE SEEN A LITTLE. PICTURES SHOW: ON MOST OF THE BLUNT NEEDLES THE WHITE PART GOES 1-3 MM OVER THE METAL. THIS IS ONLY ON ONE SIDE OF THE NEEDLE, ON THE BACKSIDE THERE IS NO IRREGULARITIES. IN THE MIDDLE YOU SEE THE MOST IRREGULARITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153967 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other