BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15G R.K. EPIDURAL NEEDLE (TW)

    MDR report key: 5666067 · Received May 19, 2016

    Report

    Report Number
    1316297-2016-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 31, 2016
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    MIA
    PMA / PMN Number
    K072005
    Removal / Correction Number
    1316297-04/20/16-001-R
    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 SUBSEQUENT INVESTIGATION, IT HAS BEEN DETERMINED THAT THE CORRESPONDING 15G R.K. EPIDURAL NEEDLE WAS MOST LIKELY RESPONSIBLE FOR THE SKIVING ISSUES WHICH OCCURRED AT THE REPORTING ACCOUNT. TO DATE, THIS ISSUE HAS BEEN ISOLATED TO THIS ONE INDIVIDUAL REPORTING ACCOUNT. REGARDLESS, EPIMED HAS OPENED AN INTERNAL CORRECTIVE ACTION TO FURTHER INVESTIGATE THE ROOT CAUSE OF THIS ISSUE. IN ADDITION, ON APRIL 20, 2016, EPIMED INITIATED A RECALL OF THE 15G RK NEEDLE. ALL QUESTIONABLE DEVICES WERE SUCCESSFULLY RECALLED, OFFICIALLY CLOSING THE RECALL REPORT ON MAY 11, 2016. PRODUCT NAME RECALLED: 15G R.K. EPIDURAL NEEDLE, CATALOG #/ REF #: (B)(4), AFFECTED LOT NUMBERS: 12157181, 12157325, AND 12157445.

    Additional Manufacturer Narrative · 1

    PER EPIMED'S COMPLAINT INVESTIGATION ((B)(4)), EPIMED BELIEVES THAT 8 OUT OF 9 RETURNED CATHETERS IN QUESTION WERE DAMAGED AS A RESULT OF THE PHYSICIAN'S AGGRESSIVE HANDLING TECHNIQUES IN COMBINATION WITH A FAILURE TO FOLLOW EPIMED'S IFU (PI-004). ONE OF THE 9 CATHETERS RETURNED APPEARED TO BE NEW AND UNUSED. EPIMED DETERMINED THROUGH CONVERSATIONS WITH THE ACCOUNT THAT THE RK INTRODUCER NEEDLE REMAINED IN SITU DURING INITIAL REMOVAL AND REPOSITIONING OF THE CATHETERS IN QUESTION. THIS FAILURE TO FOLLOW THE IFU CAUSED 4 OF THE RETURNED CATHETERS TO BE MISSING PORTIONS OF THEIR (FEP) OUTER COATING NEAR THEIR DISTAL ENDS. REGARDLESS OF THIS FINDING BY EPIMED, DR. (B)(6) STATED THAT ALL OF THE CATHETER COATING WAS ACCOUNTED FOR FOLLOWING THE COMPLETION OF EACH PROCEDURE AND THAT NO PATIENTS WERE INJURED AS A RESULT OF THE AFOREMENTIONED PROCEDURES. EPIMED BELIEVES THAT IF THE WARNING AND PRECAUTIONS CONTAINED WITHIN THE BREVI-STF IFU, PI-004 (SPRING GUIDE EPIDURAL CATHETER PRODUCTS, REV. 3) WERE FOLLOWED, IT MAY HAVE PREVENTED DAMAGE TO THE CATHETERS IN QUESTION.

    Description of Event or Problem · 1

    THIS SUBMISSION IS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED THAT HE HAD AN ISSUE WITH THE QUALITY OF 9 OF EPIMED'S BREVI-STF (A-EP-085) CATHETERS. DR. (B)(6) STATED THAT "THE OUTER COATING OF THE CATHETER IS BECOMING DISTURBED DURING REPOSITIONING OF THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323146 15G R.K. EPIDURAL NEEDLE (TW) 15G R.K. EPIDURAL NEEDLE (TW) MIA EPIMED INTERNATIONAL INC. A-NE-001 12157181

    Patients

    Seq Age Sex Outcome Treatment
    1