BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2052374 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04418
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THIS IS 3 OF 3 PRODUCTS AFFECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. ONLY PICTURE OF THE SAMPLE WAS RETURNED. THE PICTURE OF THE SAMPLE WAS VISUALLY INSPECTED AND IT THE CRACK WAS CONFIRMED. THIS CAP IS MANUFACTURED IN (B)(4) PLANT, THE PROCESS ON (B)(4) PLANT IS THE INSERTION OF SPONGE, IODINE AND PACKING. THIS PROCESS WAS REVIEWED AND NO POTENTIAL FACTOR WAS FOUND THAT CAN CAUSE THIS KIND OF OCCURRENCE; HOWEVER, THE (B)(4) PLANT (SUPPLIER OF CAPS) WAS NOTIFIED ABOUT THIS KIND OF OCCURRENCE. ACCORDING TO RESPONSE OF (B)(4) REPORTED ON (B)(4) 2011, THE INJECTION MOLDING OF MINICAP COMPONENT WAS DISCONTINUED ON (B)(4) 2011 UNTIL NEW PARAMETERS FOR THE PROCESS IS ESTABLISHED. THE (B)(4) MOLDING MACHINE STARTUP & SHUTDOWN SOP (STANDARD OPERATING PROCEDURE) WAS UPDATED TO INCLUDE NEW PARAMETERS. FOLLOWING SOP CHANGE, INJECTION MOLDING OF MINICAPS RESUMED ON (B)(4) 2011. ON BATCH REVIEW, IT WAS VERIFIED THAT 23610 UNITS WERE PACKED FOR THIS LOT NUMBER. - ALL CHEMICAL TESTS WERE FOUND TO BE SATISFACTORY. - NO DEVIATION REPORTED/OBSERVED DURING MANUFACTURING OR RELEASE RELATED CRACKED MINI CAPS. THIS BATCH NUMBER WAS RELEASED IN ACCORDANCE WITH SPECIFICATION AND WAS PROPERLY APPROVED ON ALL THE APPLICABLE TESTS PERFORMED. THERE IS NO SIMILAR COMPLAINT REGISTER FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 1 DAMAGED MINICAP. IT IS CRACKED AND LEAKS. THE SAMPLE IS AVAILABLE. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. PATIENT NOT INVOLVED. THIS REPORT IS 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SAO PAULO PS38A8

    Patients

    Seq Age Sex Outcome Treatment
    1