BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE SMALL BORE EXTENSION SETS

    MDR report key: 3264648 · Received July 19, 2013

    Report

    Report Number
    9614279-2013-00020
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 21, 2013
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). A TOTAL OF THREE SETS AND ONE 10 ML SYRINGE, ALL WITHOUT PACKAGING, WERE RECEIVED FOR EVALUATION. THE SETS WERE VISUALLY EXAMINED UNDER MAGNIFICATION AND CONFIRMED TO HAVE A CRACK ON THE MOLDED CARESITE BODY OF EACH SET. THE CRACKS STARTED FROM THE TOP OF THE CARESITE AND EXTENDED DOWN TO THE BOTTOM OF THE LUER THREADS. THE CRACKS WERE NOT ON OR NEAR THE KNIT LINES. CRAZING LINES AND STRESS MARKS WERE EVIDENT AT THE AREA OF THE CRACKS. THE CAVITY NUMBERS OF THE THREE MOLDED CARESITE VALVES WERE 26B, 18B, AND 13B, RESPECTIVELY. THERE WERE NO DAMAGES OR ABNORMALITIES OBSERVED ON THE RETURNED 10 ML SYRINGE. THE DHR RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO NONCONFORMANCES OR ABNORMALITIES WERE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. MULTIPLE FOLLOW-UP ATTEMPTS TO THE FACILITY TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ALTHOUGH THE DURATION OF USE FOR THE CARESITE VALVES COULD NOT BE CONFIRMED, IT IS INDICATED ON THE INSTRUCTIONS FOR USE (IFU) FOR THE REPORTED PRODUCT CATALOG NUMBER, "THE CARESITE LUER ACCESS DEVICE IS COMPATIBLE WITH LIPID EMULSION (CONTAINED IN TPN SOLUTIONS) AND CYTOTOXIC AGENTS CONTAINING CREMOPHOR (E.G., PACLITAXEL) FOR 24 HOURS." BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENTS. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS IN ONE INCIDENT, CUSTOMER TRIED TO INJECT HEPARIN NA BY SYRINGE. WHEN THEY TRIED TO CONNECT, THERE WAS A LARGE REPULSIVE FORCE. SO WHEN THEY CONNECTED MORE FORCEFULLY, THE HOUSING OF THE PRODUCT WAS CRACKED. IN TWO INCIDENTS, THE DEVICE WAS USED TO INJECT 5-FU. WHILE THEY INSERTED DRUG TO PATIENT, THEY FOUND LEAKAGE FROM THE HOUSING OF THE CARESITE. THERE WERE NO COMPLICATIONS OR INJURIES TO THE PATIENT RESULTING FROM THESE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337134 CARESITE SMALL BORE EXTENSION SETS CARESITE NR SMBORE EXT SET SPIN LL 8 FPA B. BRAUN OF DOMINICAN REPUBLIC NA 0061296223

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other