BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONGUARD2

    MDR report key: 14539964 · Received May 30, 2022

    Report

    Report Number
    9611423-2022-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2022
    Report Date
    May 29, 2022
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    PMA / PMN Number
    K192866
    Removal / Correction Number
    Z-1057-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT FOR 9611423-2022-00001 TO CORRECT THE INFORMATION THE PROCODE WAS INELIGIBLE FOR VMSR (THE ONB PRODUCT CODE IS NOT ELIGIBLE FOR PARTICIPATING IN THE VMSR PROGRAM), THIS WAS CORRECTED BY SUBMITTING (B)(4) INDIVIDUAL REPORTS IN ITS PLACE REPORTS NO. LIST: # MDR REPORT NUMBER 1 9611423-2022-00002; 2 9611423-2022-00003; 3 9611423-2022-00004; 4 9611423-2022-00005; 5 9611423-2022-00006; 6 9611423-2022-00007; 7 9611423-2022-00008; 8 9611423-2022-00009; 9 9611423-2022-00010; 10 9611423-2022-00011; 11 9611423-2022-00012; 12 9611423-2022-00013; 13 9611423-2022-00014; 14 9611423-2022-00015; 15 9611423-2022-00016; 16 9611423-2022-00017; 17 9611423-2022-00018; 18 9611423-2022-00019; 19 9611423-2022-00020; 20 9611423-2022-00021; 21 9611423-2022-00022; 22 9611423-2022-00023; 23 9611423-2022-00024; 24 9611423-2022-00025; 25 9611423-2022-00026; 26 9611423-2022-00027; 27 9611423-2022-00028; 28 9611423-2022-00029; 29 9611423-2022-00030; 30 9611423-2022-00031; 31 9611423-2022-00032; 32 9611423-2022-00033; 33 9611423-2022-00034; 34 9611423-2022-00035; 35 9611423-2022-00036.

    Description of Event or Problem · 0

    ON (B)(6) 2022 SIMPLIVIA HEALTHCARE LTD. HAS RECEIVED A COMPLAINT FORM B. BRAUN, THE COMPLAINT ORIGINATED IN A USA HOSPITAL, REGARDING ONGUARD2 BAG ADAPTOR SP DISCONNECTION, OR LOOSE CONNECTION, FROM IV SOLUTION-CONTAINER'S PORT. DURING FEBRUARY TO APRIL 2022, SIMPLIVIA HAS RECEIVED 26 COMPLAINTS, ALL REGARDING THE ABOVE MALFUNCTION, THE COMPLAINT INVOLVED 79 DEVICES, WHICH PRESENT 0.02% OF ALL DEVICES USED IN USA HOSPITALS AND COMPOUNDING CENTERS. IN 4 EVENTS THE DISCONNECTION INVOLVED LEAKAGE ON PATIENT OR NURSE. CAUSE OF PROBLEM: BAG ADAPTOR SP DEVICES ARE 100% TESTED FOR LEAKS IN A LEAKAGE TESTING APPARATUS, DEFECTED DEVICES ARE DISCARDED. THE LUBRICATION WITH SILICON OIL OF THE LEAKAGE-TESTING APPARATUS WAS SPECIFIC TO AN O-RING MAINTENANCE TO ALLOW SEALING BETWEEN THE APPARATUS AND THE BAG ADAPTOR SP'S SPIKE. TRACES OF SILICONE-OIL WERE IDENTIFIED ON THE EXTERNAL SIDE OF THE BAG ADAPTOR SP'S SPIKE. THE TRACES OF SILICONE-OIL MIGRATED FROM THE O-RING TO THE FIRST FEW BAG ADAPTOR SP'S TESTED FOLLOWING MAINTENANCE OF THE APPARATUS. THE ROOT CAUSE ANALYSIS IDENTIFIED THAT SILICONE-OIL RESIDUES REDUCED THE FRICTION FORCE BETWEEN THE BAG ADAPTOR SP'S SPIKE AND IV SOLUTION-CONTAINER'S SPIKE-PORT, LEADING TO THE POTENTIAL LOOSE GRIP AND DISCONNECTIONS OF THE BAG ADAPTOR SP FROM THE SOLUTION CONTAINER. NO OTHER FLAWS OR IRREGULARITIES WERE IDENTIFIED. SIMPLIVIA HAS INITIATED A RECALL ON (B)(6) 2022. THE RECALL INCLUDED ALL OF BAG ADAPTOR SP BATCHES IN USA.

    Description of Event or Problem · 0

    ON THE 17TH OF FEBRUARY 2022 SIMPLIVIA HEALTHCARE LTD. HAS RECEIVED A COMPLAINT FORM B. BRAUN, THE COMPLAINT ORIGINATED IN A USA HOSPITAL, REGARDING ONGUARD2 BAG ADAPTOR SP DISCONNECTION, OR LOOSE CONNECTION, FROM IV SOLUTION-CONTAINER'S PORT. DURING FEBRUARY TO APRIL 2022, SIMPLIVIA HAS RECEIVED (B)(4) COMPLAINTS (SOME WERE ON MULTIPUL BATCHES, THUS (B)(4) INDIVIDUAL COMPLAINTS WERE REGISTRATED), ALL REGARDING THE ABOVE MALFUNCTION, THE COMPLAINT INVOLVED (B)(4) DEVICES, WHICH PRESENT 0.02% OF ALL DEVICES USED IN USA HOSPITALS AND COMPOUNDING CENTERS. IN (B)(4) EVENTS THE DISCONNECTION INVOLVED LEAKAGE ON PATIENT OR NURSE. CAUSE OF PROBLEM: BAG ADAPTOR SP DEVICES ARE 100% TESTED FOR LEAKS IN A LEAKAGE TESTING APPARATUS, DEFECTED DEVICES ARE DISCARDED. THE LUBRICATION WITH SILICON OIL OF THE LEAKAGE-TESTING APPARATUS WAS SPECIFIC TO AN O-RING MAINTENANCE TO ALLOW SEALING BETWEEN THE APPARATUS AND THE BAG ADAPTOR SP'S SPIKE. TRACES OF SILICONE-OIL WERE IDENTIFIED ON THE EXTERNAL SIDE OF THE BAG ADAPTOR SP'S SPIKE. THE TRACES OF SILICONE-OIL MIGRATED FROM THE O-RING TO THE FIRST FEW BAG ADAPTOR SP'S TESTED FOLLOWING MAINTENANCE OF THE APPARATUS. THE ROOT CAUSE ANALYSIS IDENTIFIED THAT SILICONE-OIL RESIDUES REDUCED THE FRICTION FORCE BETWEEN THE BAG ADAPTOR SP'S SPIKE AND IV SOLUTION-CONTAINER'S SPIKE-PORT, LEADING TO THE POTENTIAL LOOSE GRIP AND DISCONNECTIONS OF THE BAG ADAPTOR SP FROM THE SOLUTION CONTAINER. NO OTHER FLAWS OR IRREGULARITIES WERE IDENTIFIED. SIMPLIVIA HAS INITIATED A RECALL ON MARCH 08, 2022. THE RECALL INCLUDED ALL OF BAG ADAPTOR SP BATCHES IN USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704185 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. UBE516,518,526,530,531,534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown