BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REINFORCED DUAL LUMEN CATHETER

    MDR report key: 6994295 · Received November 1, 2017

    Report

    Report Number
    1000160256-2017-00003
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    July 20, 2017
    Report Date
    October 27, 2017
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Removal / Correction Number
    Z-0021-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED DESTRUCTIVE TESTING ON LOT N18487-1, A GC/MS ANALYSIS OF THE ADHESIVE REMAINING ON THE EASILY DISCONNECTED PART, AND A FULL REVALIDATION OF THE ADHESIVE STRENGTH AND ENVIRONMENTAL EFFECTS OF THE CURRENT PROCESS. ADDITIONALLY, OTHER ALTERNATIVE ADHESIVES WERE ALSO INVESTIGATED. THE GC/MS ANALYSIS ON THE EASILY DISCONNECTED CATHETER SHOWED THAT THE CORRECT ADHESIVE HAD BEEN USED, ALTHOUGH THIS INFORMATION HAD NOT BEEN RECORDED ON THE FAB ORDER AT THE TIME THAT THIS LOT WAS ASSEMBLED. RECORDING OF THE ADHESIVE LOT NUMBER AND EXPIRATION DATES USED DURING ASSEMBLY WERE REQUIRED SHORTLY AFTER THIS LOT WAS MADE. QA/RA SPECIALIST II AND/OR DIRECTOR QA/RA OBSERVED THE CURRENT MANUFACTURING PROCESS AND DOCUMENTED OBSERVATIONS OF INSUFFICIENTLY CONTROLLED PROCESS STEPS AND/OR PROCESS STEPS EXPECTED TO CONTRIBUTE TO VARIATION IN THE BOND STRENGTH. OF THOSE OBSERVATIONS, KEY AREAS FOR INVESTIGATION AND IMPROVEMENT: · OBSERVATION THAT A RESIDUE ACCUMULATED ON THE OPERATOR'S HANDS AFTER HANDLING MULTIPLE EXTENSION TUBES DURING THE BONDING STEP, · OBSERVATION THAT THE ADHESIVE APPEARED TO "BEAD UP" ON THE OUTSIDE OF THE EXTENSION TUBE DURING THE DIPPING PROCESS AND DRIP OFF THE EXTENSION TUBE, · OBSERVATION THAT THE OPERATOR DIPPED THE EXTENSION TUBE 2-4 TIMES IN ADHESIVE BEFORE ACHIEVING AN EFFECTIVE BOND, · PULL TEST CONDUCTED BASED ON CURING START TIME FOR THE FIRST CATHETER BONDED, WHICH MAY RESULT IN DOWNSTREAM PARTS NOT CURING FOR THE MINIMUM REQUIREMENT OF 3 HOURS THE ROOT CAUSE OF THIS EVENT IS INSUFFICIENT MANUFACTURING PROCESS CONTROL WITH POTENTIAL FOR LOW FREQUENCY OF PARTS EXHIBITING INADEQUATE ADHESIVE BONDING.

    Description of Event or Problem · 1

    ON (B)(6) 2017, (B)(6), RECEIVED A CALL FROM (B)(4), THE DISTRIBUTOR IN (B)(4). SHE REPORTED THAT A 28F CATHETER "CAME LOOSE" DURING AN ECMO RUN. AFTER FURTHER DISCUSSION, IT BECAME EVIDENT THAT THE CLEAR TUBE HAD DISCONNECTED FROM THE HUB. SHE REPORTED THE LOT NUMBER AS N18487-1, AND PROMISED TO SEND THE CATHETER BACK AS SOON AS THE HOSPITAL RELEASED IT. SHE REPORTED THAT THE PATIENT WAS ABOUT TO COME OFF ECMO WHEN THE INCIDENT OCCURRED. PATIENT DID NOT SUFFER ANY INJURY APART FROM SOME BLOOD LOSS. ORIGEN HAS RECEIVED ONE OTHER REPORT OF CLEAR TUBE DISCONNECT FROM THIS LOT (REPORT NUMBER 1000160256-2017-00002), IN WHICH CUSTOMERS REPORTED THE EXTENSION TUBE DISCONNECTED FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772261 REINFORCED DUAL LUMEN CATHETER REINFORCED DUAL LUMEN CATHETER DWF ORIGEN BIOMEDICAL, INC. VV28F N18487-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention