BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE

    MDR report key: 1033380 · Received April 15, 2008

    Report

    Report Number
    1911916-2008-00004
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    December 28, 2007
    Manufacturer
    BD MEDICAL SYSTEMS - INDUSTRIAL SITE
    Product Code
    KYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 3/28/08, BD INITIALLY CONTACTED RN, RISK MGMT BY EMAIL AT FACILITY REQUESTING ADDITIONAL INFO FOR THE REPORTED INCIDENT. ON 4/7/08, BD DID MAKE A SECOND ATTEMPT AND CONTACTED RN BY PHONE. SHE INDICATED SHE WAS RE-CONTACTING FOLKS IN HER FACILITY TO PROVIDE THE INFO WE REQUESTED. RN DID INDICATE THAT THIS SITUATION (CAP INSIDE THE PT) MAY HAVE RESULTED FROM AN ERROR AT THEIR SITE. ON 4/11/08, BD RECEIVED THE INFO AND PHOTOS OF THE TIP CAP CONFIRMING THAT IT WAS A BD PRODUCT. WHEN BD ASKED FOR IDEAS/SUGGESTIONS AS TO HOW THE TIP CAP GOT INTO THE PT'S ABDOMEN, RN INDICATED THAT THE TIP CAP WAS INADVERTENTLY LEFT ON THE SYRINGE. FROM THE INFO PROVIDED, THIS INCIDENT APPEARS TO BE THE RESULT OF USER'S TECHNIQUE, NOT A PRODUCT MALFUNCTION. IN ADDITION, THE LOT NUMBER IS UNK, THEREFORE WE ARE UNABLE TO RUN A DEVICE HISTORY REVIEW. AS OF THIS DATE, A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER INCIDENT FOR THIS ISSUE ON THE AFFECTED REORDER NUMBER. AS IN ALL INSTANCES, REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR FOR ANY CHANGES IN MONTHLY TRENDS.

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE HOSP IN 2008 WITH ABDOMINAL PAIN. A CT SCAN SHOWED A RETAINED FOREIGN BODY THAT WAS 3CM BY 1CM WITH A RING AROUND IT. PT WAS TAKEN TO SURGERY IN 2007 FOR REMOVAL OF THE FOREIGN BODY IDENTIFIED AS THE PLASTIC CAP OF A CATHETER TIP SYRINGE (CALLED A TOOMEY SYRINGE BY THE STAFF). THE SYRINGE WAS USED TO INJECT SEPRA FILM DURING A LAPAROSCOPIC CHOLECYSTECTOMY AND LYSIS OF ADHESIONS AROUND THE GALLBLADDER IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SYRINGE 60ML BD SYRINGE CATHETER TIP 2OZ. KYZ BD MEDICAL SYSTEMS - INDUSTRIAL SITE * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization