BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE RATED EXT SET BONDED SS 8.5

    MDR report key: 12346331 · Received August 19, 2021

    Report

    Report Number
    9616066-2021-51848
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 22, 2021
    Report Date
    September 8, 2021
    Product Code
    FPA
    UDI-DI
    50885403242043
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTO OR PRODUCT WAS INVESTIGATED UNDER THIS COMPLAINT. THE CUSTOMER COMPLAINT THAT THE NURSE RE - HOOKED THE FLUSH TWICE, PRIMED THE J-LOOP AND THE BLUE PORT DID NOT FULLY SUPPRESS COULD NOT BE VERIFIED BECAUSE NO SAMPLE WAS RETURNED. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED OF THE RETURNED NEEDLE-FREE CONNECTOR (SMARTSITE). FOLLOWING A SMALL NUMBER OF SIMILAR REPORTS, BD HAS CONDUCTED AN IN-DEPTH INVESTIGATION TO IDENTIFY ANY POTENTIAL CONTRIBUTING FACTORS FOR OCCLUSION OF THIS NATURE. THE INVESTIGATION HAS DETERMINED THAT A POTENTIAL CONTRIBUTOR COULD BE THE RESULT OF AN INSUFFICIENT AMOUNT OF FLUOROSILICONE HAVING BEEN INJECTED INTO THE PISTON DURING THE ASSEMBLY PROCESS. FLUOROSILICONE IS A LUBRICANT USED TO ENSURE PROPER FUNCTIONING OF THE NEEDLE-FREE CONNECTOR WHEN ACTIVATED. HOWEVER, IN THIS INSTANCE NO SAMPLE WAS RETURNED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 22003E - 07 LOT NUMBER 20119638 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 17603 UNITS IN 1 LOT NUMBER WAS BUILT ON 25NOV2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A TREND FOR THIS OCCLUSION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. A CAPA (CORRECTIVE ACTION PREVENTATIVE ACTION) 1998036 HAS BEEN INITIATED, AND A TEAM HAS BEEN ASSEMBLED IN ORDER TO INVESTIGATE THE ISSUE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 PRESSURE RATED EXT SETS BONDED SS 8.5 WERE DIFFICULT TO FLUSH/DRAW BLOOD FROM DUE TO FLOW ISSUES/BLOCKAGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NOTICED SOMETIMES I HAVE TO RE-HOOK THE FLUSH UP TWICE WHEN I PRIME MY J LOOP LINE BECAUSE THE LITTLE BLUE PORT DOESN¿T SUPPRESS ALL THE WAY. I JUST UNHOOK AND RE-ATTACH AND IT¿S SOMETIMES FINE. OTHER TIMES YOU HOOK INTO THE FLUSH AND DETACH AND REATTACH AND IT STILL DOES NOT WORK. WE DON¿T HAVE TIME TO DEAL WITH THE CONSTANT MANIPULATION OF THE LINE. IT SHOULD FLUSH WHEN HOOKED UP." "THEY GAVE ME 3 THAT WERE GIVING THEM DIFFICULTY WITH PRIMING. I WAS ABLE TO GET 1 OF THE 3 TO WORK IMMEDIATELY WHEN TAKING OFF THE FLUSH AND REATTACHING. THE OTHER 2 TOOK MULTIPLE ATTEMPTS AND MULTIPLE PEOPLE TRYING BEFORE ALLOWING TO FLUSH, AND NEEDING A SIGNIFICANT AMOUNT OF PRESSURE TO BE ADMINISTERED." "THIS IS A LARGE PAIN POINT IN THE ED. MANY OF THE STAFF, INCLUDING MYSELF, ARE UNABLE TO FLUSH THE J LOOP AND/OR DRAW BLOOD FROM IT. THIS BECOMES AN ISSUE WHEN YOU ALREADY HAVE AN IV IN A PATIENT AND THEN THE EQUIPMENT DOES NOT WORK. MANY STAFF HAVE STATED THAT AT TIMES THEY HAVE HAD TO GO THROUGH 3-4 OF THEM TO GET ONE THAT WORKS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 PRESSURE RATED EXT SETS BONDED SS 8.5 WERE DIFFICULT TO FLUSH/DRAW BLOOD FROM DUE TO FLOW ISSUES/BLOCKAGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NOTICED SOMETIMES I HAVE TO RE-HOOK THE FLUSH UP TWICE WHEN I PRIME MY J LOOP LINE BECAUSE THE LITTLE BLUE PORT DOESN'T SUPPRESS ALL THE WAY. I JUST UNHOOK AND RE-ATTACH AND IT¿S SOMETIMES FINE. OTHER TIMES YOU HOOK INTO THE FLUSH AND DETACH AND REATTACH AND IT STILL DOES NOT WORK. WE DON¿T HAVE TIME TO DEAL WITH THE CONSTANT MANIPULATION OF THE LINE. IT SHOULD FLUSH WHEN HOOKED UP." "THEY GAVE ME 3 THAT WERE GIVING THEM DIFFICULTY WITH PRIMING. I WAS ABLE TO GET 1 OF THE 3 TO WORK IMMEDIATELY WHEN TAKING OFF THE FLUSH AND REATTACHING. THE OTHER 2 TOOK MULTIPLE ATTEMPTS AND MULTIPLE PEOPLE TRYING BEFORE ALLOWING TO FLUSH, AND NEEDING A SIGNIFICANT AMOUNT OF PRESSURE TO BE ADMINISTERED." "THIS IS A LARGE PAIN POINT IN THE ED. MANY OF THE STAFF, INCLUDING MYSELF, ARE UNABLE TO FLUSH THE J LOOP AND/OR DRAW BLOOD FROM IT. THIS BECOMES AN ISSUE WHEN YOU ALREADY HAVE AN IV IN A PATIENT AND THEN THE EQUIPMENT DOES NOT WORK. MANY STAFF HAVE STATED THAT AT TIMES THEY HAVE HAD TO GO THROUGH 3-4 OF THEM TO GET ONE THAT WORKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242933 PRESSURE RATED EXT SET BONDED SS 8.5 INTRAVASCULAR ADMINISTRATION SET FPA 22003E-07 20119638 50885403242043

    Patients

    Seq Age Sex Outcome Treatment
    1