BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15G R.K. EPIDURAL NEEDLE (TW)

    MDR report key: 5666071 · Received May 19, 2016

    Report

    Report Number
    1316297-2016-00002
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    March 30, 2016
    Report Date
    April 6, 2016
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    MIA
    PMA / PMN Number
    K072005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 #: 100-1415, AFFECTED LOT NUMBERS: 12157181, 12157325, AND 12157445.

    Additional Manufacturer Narrative · 1

    PER EPIMED'S COMPLAINT INVESTIGATION, EPIMED BELIEVES THAT THE (3) CATHETERS IN QUESTION WERE DAMAGED AS A RESULT OF THE IMPROPER HANDLING TECHNIQUES BY THE PHYSICIANS IN COMBINATION WITH A FAILURE TO FOLLOW EPIMED'S IFU. 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 CASUING THE CATHETERS TO SKIVE THEIR OUTER (FEP) COATING. EPIMED BELIEVES THAT IF THE WARNINGS AND PRECAUTIONS CONTAINED WITHIN THE BREVI-STF (B)(4) (SPRING GUIDE EPIDURAL CATHETER PRODUCTS, REV. 3) WERE FOLLOWED, IT MAY HAVE PREVENTED DAMAGE TO THE CATHETERS IN QUESTION. EPIMED CONSIDERS THIS INCIDENT ISOLATED TO THIS ACCOUNT AND WILL CONTINUE TO MONITOR FUTURE COMPLAINTS TO PREVENT ADVERSE TRENDING FROM OCCURING.

    Description of Event or Problem · 1

    THIS SUBMISSION IS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, (B)(6), MATERIALS MANAGER FOR SURGERY CENTER OF (B)(6) REPORTED THAT THE ACCOUNT HAD SOME MORE PROBLEMS WITH THREE ADDITIONAL BREVI-STF CATHETERS (A-EP-085). THIS IS THE SECOND COMPLAINT FROM THIS ACCOUNT INVOLVING SIMILAR CIRCUMSTANCES. THE FIRST COMPLAINT NUMBER (B)(4), WAS INVESTIGATED EARLIER IN THE MONTH AND HAS SINCE BEEN CLOSED. TWO INCIDENTS OCCURRED, ONE ON (B)(6) 2016, WITH DR. (B)(6) AND ONE ON (B)(6) 2016, WITH DR. (B)(6). DURING BOTH INCIDENTS, THE CATHETERS BEING USED SKIVED DURING THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323145 15G R.K. EPIDURAL NEEDLE (TW) 15G R.K. EPIDURAL NEEDLE (TW) MIA EPIMED INTERNATIONAL INC. A-NE-001 12157181 AND 12157325

    Patients

    Seq Age Sex Outcome Treatment
    1