BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FILTER NEEDLE

    MDR report key: 9315799 · Received November 13, 2019

    Report

    Report Number
    1911916-2019-01199
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    August 13, 2019
    Report Date
    November 14, 2019
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS COMPLAINT WILL BE CANCELLED. THIS IS A DUPLICATE COMPLAINT OF (B)(4), MFR REPORT # 1911916-2019-00985 THAT HAS ALREADY BEEN REPORTED FOR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FILTER NEEDLE HAD EPOXY ON THE NEEDLE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305200 BATCH, NO. 8200529. IT WAS REPORTED THAT THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. ON 19-AUG-2019, THE REPORTER CONTACTED MEDICAL INFORMATION VIA PHONE TO REQUEST A RETURN ONLY OF EYLEA. THE REPORTER STATED THAT THE PHYSICIAN NOTED ON (B)(6) 2019, THAT THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. THE PHYSICIAN DISCOVERED THE ISSUE UPON OPENING THE PACKAGING FOR THE FILTER NEEDLE RETURN RECEIVED BY QA. ONLY THE FILTER NEEDLE WAS RECEIVED. THE DEFECT WAS CONFIRMED (EPOXY ON THE NEEDLE HUB).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD FILTER NEEDLE HAD EPOXY ON THE NEEDLE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305200 BATCH NO. 8200529. IT WAS REPORTED THAT THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. ON 19-AUG-2019, THE REPORTER CONTACTED MEDICAL INFORMATION VIA PHONE TO REQUEST A RETURN ONLY OF EYLEA. THE REPORTER STATED THAT THE PHYSICIAN NOTED ON 13-AUG-2019, THAT THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. THE PHYSICIAN DISCOVERED THE ISSUE UPON OPENING THE PACKAGING FOR THE FILTER NEEDLE RETURN RECEIVED BY QA ¿ ONLY THE FILTER NEEDLE WAS RECEIVED. THE DEFECT WAS CONFIRMED (EPOXY ON THE NEEDLE HUB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108246 BD FILTER NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8200529 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other