BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSTRO FEED TBE W/Y PRT 14FR EN

    MDR report key: 12750978 · Received November 4, 2021

    Report

    Report Number
    9612030-2021-03076
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    September 15, 2021
    Report Date
    March 8, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    PIF
    UDI-DI
    10884521661639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    APPROPRIATE TERM/CODE NOT AVAILABLE IN H6: SCABS SECTION B3 HAS BEEN CORRECTED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. HOWEVER, AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO THE RELEASE OF PRODUCT. THE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED DEVICE HAD DAMAGE TO THE CONNECTOR (Y-PORT), WHICH WAS OBSERVED TO BE BROKEN AT THE Y-UNION. DURING THE INVESTIGATION, A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED, AND ALL PROCESS AND CONTROLS WERE FOUND PROPERLY FOLLOWED, INCLUDING SUB-ASSEMBLIES AND FINISHED PRODUCT ASSEMBLY AND PACKAGING. THERE WERE NO ABNORMAL CONDITIONS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. AS PART OF THE INVESTIGATION REVIEW ACTIVITIES, WE DID INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO INVESTIGATE AND DETERMINE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS, WHICH RESULTED IN A DESIGN RELATED IMPROVEMENT TO STRENGTHEN THE Y-PORT AND Y-PORT CONNECTIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CONNECTOR CRACKED DURING USE AFTER SEVERAL MONTHS CAUSING THE FEEDING TUBE TO LEAK FORMULA. AS A RESULT, THE FEEDING TUBE WAS REPLACED PREMATURELY. THERE WAS NO PATIENT INJURY AND THERE WAS NO DELAY TO TREATMENT BECAUSE OF THE INTERVENTION. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 31, 2021 STATED THAT ON (B)(6) 2021, A NURSE HAD NOTICED THAT ONE OF THE TWO TIPS OF THE TUBING WAS BROKEN SO IT WAS DECIDED TO PUT THE FEEDING ON THE SECOND TIP. ON (B)(6) 2021, A DRESSING WAS PUT ON THE ENFIT CONNECTOR OF THE TWO ADMINISTRATION SITES. THE ADMINISTRATION SITE HAD REMAINED BROKEN SINCE (B)(6) 2021 AND WAS READY TO BE DETACHED FROM THE TUBING. THE PGE SHOWED FEEDING AND SOME SCABS WITH FEEDING AROUND IT. DRESSINGS WERE DONE AGAIN AND IT WAS NOTED THAT THE TUBING WOULD BE CHANGED. ON (B)(6) 2021, THERE WERE BILIOUS FLOWS AT THE PGE SITE. ON (B)(6) 2021 THERE WAS A LEAK AT THE PGE AFTER ENTERAL HYDRATION VIA PGE. ON (B)(6) 2021, THE TUBING WAS REMOVED AND EXCHANGED BY ANOTHER TUBING FROM ANOTHER MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CONNECTOR CRACKED DURING USE AFTER SEVERAL MONTHS CAUSING THE FEEDING TUBE TO LEAK FORMULA. AS A RESULT, THE FEEDING TUBE WAS REPLACED PREMATURELY. THERE WAS NO PATIENT INJURY AND THERE WAS NO DELAY TO TREATMENT BECAUSE OF THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651476 GSTRO FEED TBE W/Y PRT 14FR EN GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF CARDINAL HEALTH 8884715148E 10884521661639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown