BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSFIX MEC SHORT SHEATH

    MDR report key: 8611686 · Received May 15, 2019

    Report

    Report Number
    1018233-2019-02559
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Report Date
    June 17, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿SHAFT TOO LONG¿. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿INCORRECT FORM LENGTH¿. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿CONTRAINDICATION DO NOT USE ON IRRITATED OR COMPROMISED SKIN. PRECAUTION ¿ DO NOT USE IF ALLERGIC REACTION OCCURS. ¿ FOR GOOD HYGIENE, CHANGE SHEATH DAILY. ¿ USE OF A SINGLE DEVICE FOR LONGER PERIODS THAN 24 HOURS MAY INCREASE THE RISK OF COMPLICATIONS. DIRECTIONS: TO APPLY 1 WASH PENIS WITH MILD SOAP AND WARM WATER. DRY THOROUGHLY. 2 TRIM PUBIC HAIR IF NECESSARY. 3 REMOVE SHEATH FROM PLASTIC INSERT (STYLES 2 & 3). 4 PLACE SHEATH FUNNEL OVER PENILE TIP. 5 SQUEEZE THE FUNNEL TO SEAL SHEATH TO PENILE TIP. 6 GENTLY PULL SHEATH TO EXPOSE PENILE SHAFT. 7 UNROLL SHEATH OVER PENIS. 8 GENTLY SQUEEZE THE SHEATH TO PROPERLY SEAL ADHESIVE TO THE SKIN. IMPORTANT: WEAR TIME MAY BE SIGNIFICANTLY REDUCED IF ADHESIVE IS NOT PROPERLY SEALED TO THE SKIN. 9 CONNECT TO DRAINAGE DEVICE. DIRECTIONS: TO REMOVE GENTLY ROLL SHEATH OFF THE PENIS. BARD AND TRANSFIX ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2016 C. R. BARD, INC. ALL RIGHTS RESERVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHEATHS WERE ABOUT 3 CM LONGER THAN USUAL. THE SHEATHS DID NOT FIT CORRECTLY AND PULLED CAUSING DISCOMFORT. THE IBC REPRESENTATIVE RECEIVED AN EMAIL ON 25-APRIL-2019 AND WAS SENT TO BD UCC FA ON 08-MAY-2019, THE CUSTOMER STATED THE BOX SAID 33MM ON IT INSTEAD OF 29MM.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEATHS WERE ABOUT 3 CM LONGER THAN USUAL. THE SHEATHS DID NOT FIT CORRECTLY AND PULLED CAUSING DISCOMFORT. THE IBC REPRESENTATIVE RECEIVED AN EMAIL ON 25-APRIL-2019 AND WAS SENT TO BD UCC FA ON 8-MAY-2019, THE CUSTOMER STATED THE BOX SAID 33MM ON IT INSTEAD OF 29MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404105 TRANSFIX MEC SHORT SHEATH MEC NNX C.R. BARD, INC. (COVINGTON) -1018233 JUCV0322

    Patients

    Seq Age Sex Outcome Treatment
    1