BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP

    MDR report key: 7243952 · Received February 6, 2018

    Report

    Report Number
    1911916-2018-00011
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 12, 2018
    Report Date
    March 2, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED NO SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THREE PHOTOS WERE ATTACHED. TWO OF THE PHOTOS SHOW A PARTICLE THAT APPEARS BLACK IN ONE PHOTO, AND GRAYISH-WHITE IN THE OTHER ON A PLAIN WHITE BACKGROUND. THERE IS NOTHING IN THE PHOTOS TO REFERENCE THE SIZE OF THE PARTICLE. THE FILTER IN A FILTER HUB IS A 5 MICRON FILTER, AND IT WOULD HAVE TO BE A MINUTE PARTICLE TO PASS THROUGH THE NEEDLE INTO THE SYRINGE. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. DHR REVIEW: BATCH 6152796 - FORTY-SEVEN VISUAL INSPECTIONS WERE PERFORMED ON 2,820 PARTS WITH ZERO DEFECTS NOTED. DAILY CLEANING WAS PERFORMED EIGHT TIMES DURING THE PACKAGING OF THIS BATCH. ASSEMBLY BATCH 6153637 HAD 162 VISUAL INSPECTIONS PERFORMED ON 8,050 PARTS WITH ZERO DEFECTS NOTED. DAILY CLEANING WAS PERFORMED 20 TIMES DURING THE ASSEMBLY OF THIS BATCH. ASSEMBLY BATCH 6120576 WAS ALSO USED IN BATCH 6152796. ONE-HUNDRED AND ELEVEN VISUAL INSPECTIONS WERE PERFORMED ON 5,700 PARTS WITH ZERO DEFECTS NOTED. DAILY CLEANING WAS PERFORMED THIRTEEN TIMES DURING THE ASSEMBLY OF THIS BATCH. BATCH 6152798 ¿ FORTY-TWO VISUAL INSPECTIONS WERE PERFORMED ON 2,520 PARTS WITH ZERO DEFECTS NOTED. DAILY CLEANING WAS PERFORMED FIVE TIMES DURING THE PACKAGING OF THIS BATCH. ASSEMBLY BATCH 6153637 HAD 162 VISUAL INSPECTIONS PERFORMED ON 8,050 PARTS WITH ZERO DEFECTS NOTED. DAILY CLEANING WAS PERFORMED 20 TIMES DURING THE ASSEMBLY OF THIS BATCH. INVESTIGTION CONCLUSION: POSSIBLE ROOT CAUSE: UNABLE TO DETERMINE BASED ON THE ATTACHED PHOTOS.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A PIECE OF FOREIGN MATTER AND A PHOTO WAS RECEIVED AND AN INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR WAS ABOUT TO GIVE MEDICATION FOREIGN MATTER WAS FOUND IN A BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89375 BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 6152796 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other