BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15G R.K. EPIDURAL NEEDLE (TW)

    MDR report key: 5666077 · Received May 19, 2016

    Report

    Report Number
    1316297-2016-00003
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 21, 2016
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    MIA
    PMA / PMN Number
    K072005
    Removal / Correction Number
    1316297-042016-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EPIMED PREVIOUSLY BELIEVED THAT THE CATHETERS IN QUESTION WERE BECOMING DAMAGED (SKIVING) AS A RESULT OF THE IMPROPER HANDLING TECHNIQUES USED BY THE PHYSICIANS IN COMBINATION WITH A FAILURE TO FOLLOW EPIMED'S IFU. HOWEVER, THROUGH THE MOST RECENT COMPLAINT INVESTIGATION, EPIMED HAS DETERMINED THAT THE CORRESPONDING 15G RK NEEDLE MAY BE RESPONSIBLE FOR THE SKIVING ISSUES WHICH OCCURRED DURING THIS COMPLAINT AND ALSO THE PREVIOUS COMPLAINTS ((B)(4)) FROM THIS ACCOUNT. TO DATE, THIS ISSUE HAS BEEN ISOLATED TO THIS ONE INDIVIDUAL ACCOUNT. REGARDLESS, EPIMED HAS OPENED AN INTERNAL CORRECTIVE ACTION TO FURTHER INVESTIGATE THE ROOT CAUSE OF THIS ISSUE. IN ADDITION, EPIMED HAS NOTIFIED THEIR FDA DISTRICT RECALL COORDINATOR AND HAVE INITIATED A RECALL ON: PRODUCT NAME: 15G R.K. EPIDURAL NEEDLE, CATALOG #/ REF #: 100-1415, AFFECTED LOT NUMBERS: 12157181, 12157325, AND 12157445.

    Description of Event or Problem · 1

    ON (B)(6) 2016, (B)(4), EPIMED SALES CONSULTANT, REPORTED THAT THE SURGERY CENTER OF (B)(6) HAD ADDITIONAL SKIVING PROBLEMS WITH THE REPLACEMENT BREVI-STF CATHETERS AND RK NEEDLES. THE CATHETERS SKIVED WHILE USING THEM WITH THE 100% INSPECTED RK NEEDLES WHICH WERE SENT AS REPLACEMENTS DURING COMPLAINT INVESTIGATION (B)(4). THIS IS THE THIRD COMPLAINT FROM THIS ACCOUNT INVOLVING SIMILAR CIRCUMSTANCES. THE FIRST COMPLAINT NUMBER (B)(4) WAS INVESTIGATED IN MARCH AND HAS SINCE BEEN CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323085 15G R.K. EPIDURAL NEEDLE (TW) 15G RK NEEDLE MIA EPIMED INTERNATIONAL INC. A-NE-001 12157445

    Patients

    Seq Age Sex Outcome Treatment
    1