BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NOKOR FILTER NEEDLE

    MDR report key: 10742815 · Received October 27, 2020

    Report

    Report Number
    1911916-2020-00971
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    September 22, 2020
    Report Date
    November 16, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305200 AND LOT NUMBER 9141505. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY WITH A NEEDLE TIP THROUGH THE PLASTIC SHIELD. THE REPORTED DEFECT WAS INDUCED WHEN RECAPPING THE NEEDLE ASSEMBLY. BASED ON THE INVESTIGATION AND THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED; HOWEVER, THIS IS AN OFF-LABEL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NOKOR¿ FILTER NEEDLE PIERCED THROUGH THE SHIELD AFTER USE AND STUCK A STAFF MEMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN RECAPPING A BD NEEDLE THE NEEDLE PIERCED THE SIDE OF THE CAP AND STUCK A STAFF."

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305200 AND LOT NUMBER 9141505. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. NO SAMPLE WAS RECEIVED AND NO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE REPORTED DEFECT WAS INDUCED WHEN RECAPPING THE NEEDLE ASSEMBLY. IT IS IMPORTANT TO REFER TO THE INSTRUCTIONS FOR USE WHEN USING THIS PRODUCT. INSTRUCTIONS FOR USE STATE THESE PRODUCTS SHOULD NOT BE RECAPPED. INVESTIGATION CONCLUSION: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. THE REPORTED SYMPTOM WAS INDUCED WHEN RECAPPING THE NEEDLE ASSEMBLY; THIS SHOULD NOT BE DONE. THE INSTRUCTIONS FOR USE STATES THAT THESE PRODUCTS SHOULD NOT BE RE CAPPED. A REVIEW OF THE APPLICABLE FMEA/PEURA ((B)(4)) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE DESCRIPTION: OFF LABEL USE. RATIONALE: BASED ON THE INVESTIGATION AND THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED; HOWEVER, THIS IS AN OFF-LABEL USE. WE WILL CONTINUE MONITORING THIS PRODUCT AND LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NOKOR¿ FILTER NEEDLE PIERCED THROUGH THE SHIELD AFTER USE AND STUCK A STAFF MEMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN RECAPPING A BD NEEDLE THE NEEDLE PIERCED THE SIDE OF THE CAP AND STUCK A STAFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208902 BD NOKOR FILTER NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305200 9141505 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other