BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K034020

    MDR report key: 949154 · Received November 16, 2007

    Report

    Report Number
    1720496-2007-00246
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    October 23, 2007
    Report Date
    October 23, 2007
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED, AND THE CAUSE APPEARS TO BE USER RELATED. THE CONNECTOR ASSEMBLY WAS RECEIVED WITH THE PROXIMAL CONNECTOR LOCKED TO THE DISTAL CONNECTOR. NOT A SINGLE PIECE OF THE GROSHONG PICC TUBING WAS ATTACHED TO THE CONNECTOR. THE PICC WAS NOT RETURNED FOR EVAL. THE COMPRESSION SLEEVE HAD BEEN PUSHED INTO THE TAPER OF THE DISTAL CONNECTOR, WHICH CAUSED THE SLEEVE TO COMPRESS AROUND THE CANNULA. HAD A PROPER CONNECTION BEEN MADE, THE GROSHONG TUBING WOULD HAVE BEEN COMPRESSED BETWEEN THE COMPRESSION SLEEVE AND THE CANNULA. THE CATHETER WOULD BREAK PRIOR TO A COMPLETE SEPARATION OF THE CATHETER FROM THE CONNECTOR, LEAVING A SEGMENT OF THE TUBING STILL ATTACHED INSIDE THE CONNECTOR. IT APPEARS THAT THE TUBING WAS NEVER PROPERLY ATTACHED TO THE CONNECTOR. THE INCIDENT REPORTEDLY OCCURRED THE DAY THE CATHETER WAS PLACED, WHICH ALSO INDICATES THAT AN IMPROPER CONNECTION WAS MADE. THE PRODUCT IFU INSTRUCTS THE USER TO "GENTLY ADVANCE THE CATHETER ONTO THE CONNECTOR BLUNT UNTIL IT BUTTS UP AGAINST THE COLORED PLASTIC BODY. THE CATHETER SHOULD LIE FLAT ON THE BLUNT WITHOUT ANY KINKS". AT THAT TIME THE DISTAL AND PROXIMAL CONNECTORS SHOULD BE MATED AND LOCKED TOGETHER. NO MANUFACTURING DEFECTS WERE FOUND ON THE RETURNED CONNECTOR ASSEMBLY. A CHR OF LOT #RERE0486 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC WAS INSERTED IN 2007 TO 57 CM. PICC NOT TRIMMED PRIOR TO BEING PLACED ON CONNECTION STYLET. PICC INSPECTED 5 HOURS POST INSERTION AND INTACT. WHEN PICC ACCESSED AT 10AM ON THE SAME DAY, IT WAS NOTED AS BEING COMPLETELY DETACHED FROM NXT EXTENSION AND PICC WAS INSIDE PATIENT. ON X-RAY, PICC NOTES AS BEING IN RT VENTRICLE/PULMONARY VESSELS. PICC REMOVED VIA SNARE ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K034020 LJS C.R. BARD, INC. (BASD) RERE0486

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention