BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F6 SKATER SINGLE STEP STRING

    MDR report key: 1935979 · Received December 9, 2010

    Report

    Report Number
    9613246-2010-00005
    Event Type
    Injury
    Date Received
    December 9, 2010
    Report Date
    December 8, 2010
    Manufacturer
    PBN MEDICALS DENMARK A/S
    Product Code
    DQX
    PMA / PMN Number
    K050873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM IS CLEARLY RELATED TO INCORRECT USE OF THE PRODUCT, AS THE IFU HAS NOT BEEN FOLLOWED. THE PURPLE CAP IS DISTRIBUTED WITH THE PRODUCT AND THE IFU SAYS THAT IT SHALL BE USED. THE ACTION INITIATED AND COMPLETED INVOLVES COMPLETION OF A "CUSTOMER F/U REPORT". THE CUSTOMER WAS VISITED ON (B)(6) IN ORDER TO EMPHASIZE THE NEED FOR USE ON THE PURPLE CAP AS DESCRIBED IN THE IFU. BASED ON THE DISCUSSION, THE CUSTOMER CHOSE TO USE AN ALTERNATIVE NON-LOCKING SKATER CATHETER FROM PBN MEDICAL (B)(4) A/S WITHOUT STRING, AS THIS CATHETER DOES NOT REQUIRE THE USE OF THE PURPLE CAP.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE DISTRIBUTORS SALES MANAGER: I HAD A MEETING WITH DR (B)(6) AT THE (B)(6) AND DISCUSSED THE PROBLEMS WITH THE (B)(4) SKATER. HE NOTICED, A HIGH INCIDENCE OF PNEUMOTHORAX ON THE WARDS AFTER PTS HAD BEEN FITTED WITH THE SKATER LOCKING PIGTAILS FOR A CHEST DRAIN. THERE ARE 12 RADIOLOGISTS WHO PLACE THE SKATERS AND WHEN HE ASKED THEM ABOUT THEIR PRACTICE IN PLACING THE SKATER, HE FOUND THAT 8-9 OF THEM DID NOT PLACE THE PURPLE BUNG ON THE END OF THE CATHETER. HE DID NOT TEST ON THE SKATER AND FOUND THAT IF THE PURPLE BUNG WAS NOT ATTACHED OR NOT SCREWED ON TIGHTLY THERE WAS AIR LEAKAGE UNDERWATER. AS A RESULT, THE (B)(6) HOSPITAL HAS CHANGED FROM SKATER NON-LOCKING PIGTAIL CATHETERS. HE WILL BE DOING ANOTHER AUDIT IN THE NEW YEAR AND EXPECTS THE INCIDENCE OF PNEUMOTHORAX TO HAVE DROPPED. THE RADIOLOGY MANAGER THOUGHT THAT DR (B)(6) SHOULD PASS THIS INFO ON TO THE (B)(4), WHICH HE SUBSEQUENTLY DID. I HAVE LOOKED AT THE PRODUCT COMPLAINT FORM AND THE INFO IT ASKS FOR. I CAN NOT PROVIDE THE FOLLOWING INFO, SALES ORDER NUMBERS, LOT NUMBERS, PRODUCT SAMPLES FOR RETURN, AND USED SAMPLES. THERE HAS BEEN NO SERIOUS INJURY OR DEATH REPORTED TO ME AND THE PROCEDURE WAS A CHEST DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F6 SKATER SINGLE STEP STRING SKATER CATHETER DQX PBN MEDICALS DENMARK A/S 756506025 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other