BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR C35-O

    MDR report key: 11751042 · Received April 30, 2021

    Report

    Report Number
    2243072-2021-01305
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THATCONNECTOR C35-O DISCONNECTED FROM THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN.   IT WAS REPORTED THAT THE PHASEAL CONNECTOR HAD DISCONNECTED FROM THE LOWSORB TUBING, BUT BOTH PARTS WERE STILL CONNECTED AND ATTACHED TO THE CVC LUMEN.   VERBATIM: REPORTED DATE: 03/29/2021, EVENT DATE: 03/29/2021. ITEM NUMBER: NOT REPORTED; LOT NUMBER: NOT REPORTED; ITEM RETAINED IN DEFECT DEPOT?: NOT REPORTED; PICTURE: NOT REPORTED. THE NURSE AIDE ASKED FOR THE NURSE BECAUSE THE PATIENT WAS BLEEDING. I ENTERED THE PATIENT'S ROOM AND NOTED BLOOD ON HIS GOWN. THE PHASEAL CONNECTOR HAD DISCONNECTED FROM THE LOWSORB TUBING, BUT BOTH PARTS WERE STILL CONNECTED AND ATTACHED TO THE CVC LUMEN. THE PATIENT WAS BLEEDING THROUGH THIS. THE DISCONNECT HAPPENED BETWEEN THE PHASEAL INJECTOR AND TACRO LOW SORB TUBING. BLOOD BACK FLOWED FROM THE INJECTOR AND LEAKED TO LINEN. D.1. MEDICAL DEVICE BRAND NAME: CONNECTOR C35-O. D.2. MEDICAL DEVICE TYPE: ONB. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A. (SAN AGUSTIN). D.4. MEDICAL DEVICE CATALOG#: 515070. D.4. UNIQUE IDENTIFIER (UDI)#: (B)(4). G.1. MANUFACTURING LOCATION: BECTON DICKINSON, S.A. (SAN AGUSTIN). G.5. PMA / 510(K)#: K181221. H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED, AND ADDITIONAL RETAINED SAMPLES CANNOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THATCONNECTOR C35-O DISCONNECTED FROM THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN.   IT WAS REPORTED THAT THE PHASEAL CONNECTOR HAD DISCONNECTED FROM THE LOWSORB TUBING, BUT BOTH PARTS WERE STILL CONNECTED AND ATTACHED TO THE CVC LUMEN.   VERBATIM: REPORTED DATE: 03/29/2021, EVENT DATE: (B)(6) 2021, ITEM NUMBER: NOT REPORTED; LOT NUMBER: NOT REPORTED; ITEM RETAINED IN DEFECT DEPOT?: NOT REPORTED; PICTURE: NOT REPORTED. THE NURSE AIDE ASKED FOR THE NURSE BECAUSE THE PATIENT WAS BLEEDING. I ENTERED THE PATIENT'S ROOM AND NOTED BLOOD ON HIS GOWN. THE PHASEAL CONNECTOR HAD DISCONNECTED FROM THE LOWSORB TUBING, BUT BOTH PARTS WERE STILL CONNECTED AND ATTACHED TO THE CVC LUMEN. THE PATIENT WAS BLEEDING THROUGH THIS. THE DISCONNECT HAPPENED BETWEEN THE PHASEAL INJECTOR AND TACRO LOW SORB TUBING. BLOOD BACK FLOWED FROM THE INJECTOR AND LEAKED TO LINEN.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ OPTIMA CONNECTOR DISCONNECTED FROM THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN.   IT WAS REPORTED THAT THE PHASEAL CONNECTOR HAD DISCONNECTED FROM THE LOWSORB TUBING, BUT BOTH PARTS WERE STILL CONNECTED AND ATTACHED TO THE CVC LUMEN.   VERBATIM: REPORTED DATE: 03/29/21 EVENT DATE: (B)(6) 2021. ITEM NUMBER: NOT REPORTED; LOT NUMBER: NOT REPORTED; ITEM RETAINED IN DEFECT DEPOT? NOT REPORTED; PICTURE: NOT REPORTED. THE NURSE AIDE ASKED FOR THE NURSE BECAUSE THE PATIENT WAS BLEEDING. I ENTERED THE PATIENT'S ROOM AND NOTED BLOOD ON HIS GOWN. THE PHASEAL CONNECTOR HAD DISCONNECTED FROM THE LOWSORB TUBING, BUT BOTH PARTS WERE STILL CONNECTED AND ATTACHED TO THE CVC LUMEN. THE PATIENT WAS BLEEDING THROUGH THIS. THE DISCONNECT HAPPENED BETWEEN THE PHASEAL INJECTOR AND TACRO LOW SORB TUBING. BLOOD BACK FLOWED FROM THE INJECTOR AND LEAKED TO LINEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652518 CONNECTOR C35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1