BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PUREHUB

    MDR report key: 18400934 · Received December 27, 2023

    Report

    Report Number
    1911916-2023-00917
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    December 12, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    QBP
    PMA / PMN Number
    K193190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. H3 OTHER TEXT: SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED THE FOAM INSERT HAD BECOME STUCK IN THE CATHETER HUB. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A HUMAN HAND HOLDING A PUREHUB CONNECTED TO A TUBE. THE SECOND PHOTO SHOWS AN EMPTY PUREHUB CAP WITH A DISCOLORED ELONGATED SPONGE NEXT TO IT. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. AS THE MATERIAL AND LOT NUMBERS PROVIDED ARE 'UNKNOWN,' A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. PLEASE REMEMBER TO REVIEW THE INSTRUCTIONS FOR USE, SPECIFICALLY THE INTENDED PURPOSE AND CONTRAINDICATION SECTIONS. WHEN PUREHUB IS USED OUTSIDE OF THESE LIMITS, THE RISK OF ISSUES INCREASES.

    Description of Event or Problem · 0

    I WORK AS AN ANAESTHETIST IN SPECIALIZED OUTPATIENT PALLIATIVE CARE. THE FOLLOWING SITUATION WAS DESCRIBED TO ME YESTERDAY DURING A HOME VISIT: THE PATIENT RECEIVED A PICC CATHETER IN HOSPITAL AFTER HIS PORT BECAME INFECTED. A HOME CARER IS SUPPLYING THE PATIENT WITH PE. IT HAD HAPPENED TWICE IN THE LAST FEW DAYS THAT THE PE DID NOT GO IN AND ALARMED THE PUMP A CATHETER BLOCKAGE WAS SUSPECTED. AFTER ASPIRATION, THERE WAS "ABSORBENT COTTON" IN THE SYRINGE. THE WIFE PICKED UP THE ASPIRATE AND WAS ABLE TO SHOW IT TO ME. IT WAS THE FOAM INSERT OF THE PUREHUB CAP. THE ONLY WAY I CAN EXPLAIN THIS IS THAT THE INSERT HAD BECOME STUCK IN THE CATHETER HUB AND THE CAP WAS REMOVED WITHOUT THE CONTENTS. AS A RESULT, NO FLOW WAS POSSIBLE FOR THE PE. THIS RAISES QUESTIONS: HOW CAN SUCH ADHESIONS OCCUR? HOW CAN THE FOAM PLUG BE HYGIENICALLY REMOVED FROM THE CATHETER HUB? IS THERE ANY INDICATION THAT THE COMPLETENESS OF THE PUREHUB SHOULD/MUST BE CHECKED AFTER DISCONNECTION? WHAT CAN BE DONE TO AVOID SUCH INCIDENTS?

    Description of Event or Problem · 0

    I WORK AS AN ANAESTHETIST IN SPECIALIZED OUTPATIENT PALLIATIVE CARE. THE FOLLOWING SITUATION WAS DESCRIBED TO ME YESTERDAY DURING A HOME VISIT: THE PATIENT RECEIVED A PICC CATHETER IN HOSPITAL AFTER HIS PORT BECAME INFECTED. A HOME CARER IS SUPPLYING THE PATIENT WITH PE. IT HAD HAPPENED TWICE IN THE LAST FEW DAYS THAT THE PE DID NOT GO IN AND ALARMED THE PUMP A CATHETER BLOCKAGE WAS SUSPECTED. AFTER ASPIRATION, THERE WAS "ABSORBENT COTTON" IN THE SYRINGE. THE WIFE PICKED UP THE ASPIRATE AND WAS ABLE TO SHOW IT TO ME. IT WAS THE FOAM INSERT OF THE PUREHUB CAP. THE ONLY WAY I CAN EXPLAIN THIS IS THAT THE INSERT HAD BECOME STUCK IN THE CATHETER HUB AND THE CAP WAS REMOVED WITHOUT THE CONTENTS. AS A RESULT, NO FLOW WAS POSSIBLE FOR THE PE. THIS RAISES QUESTIONS: - HOW CAN SUCH ADHESIONS OCCUR? - HOW CAN THE FOAM PLUG BE HYGIENICALLY REMOVED FROM THE CATHETER HUB? - IS THERE ANY INDICATION THAT THE COMPLETENESS OF THE PUREHUB SHOULD/MUST BE CHECKED AFTER DISCONNECTION? - WHAT CAN BE DONE TO AVOID SUCH INCIDENTS? -------------------------------------------------------------------------------------------------- INFORMATION RECEIVED ON 02/JAN/2024 ATTACHED YOU WILL FIND PICTURES FROM THE PRODUCT AS IT WAS FOUND BY THE NURSE DURING THE LAST VISIT. THE PROBLEM IST NOT UNKNOWN TO THE NURSE, ACCORDING TO THE WIFE OF THE PATIENT. THE FOAM LINING INSIDE THE SEALING CAP CAN GET GLUED TO THE CONE OF THE PICC AND GETS STUCK THERE. I THINK POSSIBLE CAUSES MIGHT BE AN INAPPROPRIATE FIXING OF THE FOAM LINING OR AN INSUFFICIENT FLUSHING OF THE CATHETER HUB AFTER DISCONNECTION OF THE PARENTERAL FEEDING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324663 UNKNOWN PUREHUB CAP, DEVICE DISINFECTANT QBP BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown