BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1871868 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04503
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS WAS DUE TO POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS COMPLETED AND FOUND TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBER (10D12H25), WITH NO DEFECTS NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    A PT'S MOTHER CONTACTED OUR (B)(4) AFFILIATE ON (B)(6) 2010 TO REPORT THE PT RECEIVED A 4 TO 5 DAY TRIAL SUPPLY OF 1-DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A). NARAFILCON A CONTACT LENSES ARE NOT MARKETED IN THE U.S. WHILE WEARING THE LENSES THE PT DEVELOPED PAIN, NUMBNESS, TEARING OD AND THE PT'S OD EYE LID WAS SWOLLEN. THE PT VISITED (B)(6) EYE CLINIC AND WAS DIAGNOSED WITH "CORNEAL STAINING" AND THE CORNEA WAS "SCRAPED." THE PT WAS INSTRUCTED TO DISCONTINUE CONTACT LENS (CL) WEAR FOR 30 DAYS, VISIT THE CLINIC ONCE A WEEK AND WAS PRESCRIBED "2 KINDS OF EYE DROPS." ON (B)(4), A FOLLOW-UP TO THE PT'S MOTHER WAS MADE, SHE SAID THE PT SEEMS TO HAVE NO SUBJECTIVE SYMPTOMS WHILE WEARING GLASSES. WE REQUESTED THE PT'S MOTHER SUBMIT A WRITTEN CONSENT TO ALLOW US TO DISCUSS WITH THE TREATING ECP. ON (B)(4) 2010 WE RECEIVED THE CONSENT FORM AND THE ECP'S MEDICAL CERTIFICATION FORM, WHICH STATED THE EVENT OCCURRED ON (B)(6) 2010 AND THE PT WAS SEEN AT (B)(6) EYE CLINIC ON (B)(6) 2010 COMPLAINING OF FOREIGN BODY SENSATION OD. THE PT WAS DIAGNOSED WITH CORNEAL FOREIGN BODY OD. THE ECP NOTED INJECTION, FOREIGN BODY IN THE CORNEA AND A "PARTLY" ULCERATED CORNEA OD. THE FOREIGN BODY WAS REMOVED FROM THE OD ON (B)(6) 2010, BUT THE CORNEAL ULCERATION PERSISTED AND THE PT WAS TREATED WITH ANTIBIOTICS. THE PT WAS SEEN AT THE CLINIC ON (B)(6) 2010. THE CLINIC WAS CONTACTED ON (B)(4) 2010 AND AN ECP PROVIDED THE FOLLOWING INFORMATION. "THE PT SEEMS TO HAVE LEFT UNTREATED WITHOUT CL OFF FOR 2 DAYS AFTER GETTING DUST INTO OD." "THE PT HAD SWELLING AND REDNESS, AND THEN FINALLY PRESENTED TO THE CLINIC. THE ECP BELIEVES THAT THE PT WAS INITIALLY SEEN AT THE CLINIC MORE THAN FOUR DAYS AFTER THE EVENT OCCURRED. THE UNTREATED PART OF THE EYE RESULTED IN "ULCERATION." THE FOREIGN BODY WAS NOT CL BUT DUST. THE PT'S CONDITION HAS IMPROVED. THE PT IS IRRESPONSIBLE, AND THE PT IS STILL INSTRUCTED TO DISCONTINUE CL WEAR, KEEPING THE PT FROM CL WEAR. THIS EVENT WAS NOT RELATED TO CL. THE SYMPTOM OCCURRED BECAUSE THE PT LEFT UNTREATED. THE ECP REFUSED A FACE-TO-FACE MEDICAL INTERVIEW." THE PRODUCT AND LOT NUMBER WERE NOT PROVIDED. NO ADDITIONAL INFORMATION IS EXPECTED. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR (B)(6). THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. PD THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. ON AN UNREPORTED DATE IN 2010, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO PD THERAPY. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WITH REGARDS TO PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP DISCONNECT CAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R