BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE ADDITIV PRIMARY I.V.SET

    MDR report key: 2053367 · Received March 16, 2011

    Report

    Report Number
    9614279-2011-00003
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 28, 2010
    Report Date
    March 14, 2011
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K790062
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 60197445, 61093847. ADD'L EXPIRATION DATES: 04/30/2015, 06/30/2015. ADD'L DEVICE MANUFACTURE DATES: 07/2010, 05/2010. THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. HOWEVER, 3 UNUSED REP IV SETS WERE RETURNED, WITHOUT SPECIFIC LOT IDENTIFICATION. AN UNIDENTIFIED MATING TUBING SET WAS ALSO RETURNED. VISUAL EVAL NOTED SILICONE ON THE PISTONS OF THE VALVES ON SAMPLES #1 AND #3, HOWEVER, NO POOLING OR DROPLETS OF SILICONE WERE NOTED. THE MALE SPIN LOCK ADAPTER FROM THE MATING SET WAS INDIVIDUALLY CONNECTED TO BOTH VALVES ON SAMPLES #1 THROUGH # 3 BY FULLY ROTATING THE COLLAR. ALL SIX CONNECTIONS OF THE VALVE AND ADAPTER WERE NOTED TO BE TIGHT. SAMPLES # 1 THROUGH # 3 WERE THEN PRIMED AND A MALE SPIN LOCK ADAPTER WAS CONNECTED TO EACH VALVE. THE MATING SET WAS THEN ALSO PRIMED. THE MALE SPIN LOCK ADAPTER FROM THE MATING SET WAS CONNECTED TO THE PROXIMAL VALVE ON SAMPLE #1. THE SETS WERE THEN ALLOWED TO HANG FREELY FOR A 24 HOURS PERIOD. THE SCREW TOGETHER JOINTS OF THE SIX VALVES TO A MALE SPIN LOCK ADAPTER DID NOT LOOSEN OR DISCONNECT. FURTHERMORE, SAMPLES # 1 THROUGH # 3 WERE THEN FUNCTIONALLY TESTED FOR LEAKAGE AS PER SPEC, WITH PASSING RESULTS. DURING MFG THE OUTSIDE DIAMETER BELOW THE MIDDLE SEAL AND THE OUTSIDE DIAMETER OF THE UPPER SEAL OF THE VALVE PISTON ARE LUBRICATED WITH (B)(4) FLUID. IT IS TO BE NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU) OF THE TUBING SET. "TO ACCESS ULTRASITE INJECTION SITE: SWAB INJECTION SITE FOR 3 SECONDS AND ALLOW TO AIR DRY PRIOR TO USE PER INSTITUTIONAL PROTOCOL. USE A LUER LOCK CONNECTOR WITHOUT A NEEDLE, FLUSH PER INSTITUTIONAL PROTOCOL." THE RETURNED REP IV SETS PASSED ALL VISUAL AND PHYSICAL TESTING PER SPEC AND THE REPORTED DISCONNECTION COULD NOT BE DUPLICATED. WITHOUT THE ACTUAL SAMPLE TO EVALUATE, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOTS WITH NO NON-CONFORMANCES NOTED. THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE AGAINST THE CATALOG NUMBER, THE REPORTED LOT NUMBERS, OR THE SUBASSEMBLED VALVE ON THIS SET. WE CONTINUOUSLY MONITOR PRODUCT INCIDENT REPORTS TO IDENTIFY TRENDS WHICH MIGHT AFFECT OUR PRODUCTS. NO ADVERSE TRENDS HAVE BEEN IDENTIFIED WITH THE REPORTED PRODUCT.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE CUSTOMER'S DOCUMENTATION: REPORTS, EXCESS LUBRICANT IN THE "Y" SITE THAT RESULTED IN UNPREDICTABLE DISCONNECTIONS OF THE SECONDARY SET AND SPILLS OF CHEMOTHERAPEUTIC DRUGS. ADD'L INFO PROVIDED BY THE CUSTOMER INDICATED THERE WERE NO PT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE ADDITIV PRIMARY I.V.SET UNIVERSAL I.V.SET FPA B. BRAUN DOMINICAN REPUBLIC NA 61097444

    Patients

    Seq Age Sex Outcome Treatment
    1 Other