BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 4434660 · Received January 20, 2015

    Report

    Report Number
    2032282-2015-00002
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    January 12, 2015
    Report Date
    January 12, 2015
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: MOISTURE IN THE OUTER PACKAGING MAY BE A POTENTIAL INDICATOR FOR A BREACH IN THE INTEGRITY OF THE OUTER PACKAGE, WHICH IN TURN MAY CAUSE A POTENTIAL CONTAMINATION OF THE STERILE SURGICAL FIELD. AFTER CONSIDERATION OF POTENTIAL WORSE-CASE CLINICAL SCENARIOS, ADVERSE HEALTH CONSEQUENCES MAY OCCUR IF THIS DEFECT WERE TO RECUR. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE INVESTIGATION RESULTS OF THE SAMPLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REQUEST PER FDA LETTER DATED 25-FEB-2015 SUBJECT: REPORT NUMBER: 2032282-2015-00002/BAXTER REFERENCE: CMPLNT-(B)(4): RESULTS FOR ANY INVESTIGATION, EVALUATION, AND/OR FAILURE ANALYSIS, INCLUDING UNDERLYING CAUSE IDENTIFICATION, RELEVANT TO THE REPORTED EVENT: ONE UNIT CARTON OF FLOSEAL, LOT#: VNY1N022-AA WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE SAMPLE FOUND THE GELATIN AND THROMBIN POUCH WERE CLOSED AND ORIGINALLY SEALED. THE OUTER PACKAGING (UNIT CARTON) WAS WET AND THE ORIGINAL SEAL WAS NOT INTACT. THE COMPLAINT WAS CONFIRMED. A BATCH REVIEW PERFORMED FOR THE REPORTED LOT DID NOT REVEAL ANY ABNORMALITIES OR DEVIATIONS WHICH COULD HAVE LED TO THE REPORTED ISSUE. ALL RELEASE/TESTING SPECIFICATIONS WERE MET. RETENTION SAMPLE REVIEW DID NOT SHOW ANY DEVIATIONS. NO DEFECTIVE COMPONENT WAS IDENTIFIED. THE MOISTURE IN THE OUTER PACKAGING (UNIT CARTON) IS POSSIBLY A RESULT OF CUSTOMER USAGE OR STORAGE; HOWEVER NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED. NO TREND WAS IDENTIFIED FOR THIS COMPLAINT ISSUE. BAXTER FOLLOW-UP MEDICAL ASSESSMENT: SAMPLE INVESTIGATION HAS EXCLUDED A BREACH IN STERILITY OF THE OVER POUCH (SOFT BLISTERS). NO ADVERSE HEALTH CONSEQUENCES ARE EXPECTED FROM MOISTURE ON THE OVER POUCH, THUS THE CASE IS DEEMED NOT REPORTABLE. AN EXPLANATION FOR THE REASON FOR THIS OCCURRENCE BASED ON YOUR FOLLOW-UP WITH THE REPORTING FACILITY OR INDIVIDUAL: NO DEFINITIVE ROOT CAUSE HAS BEEN IDENTIFIED. A COMPLETE DESCRIPTION OF INVESTIGATION AND ANALYSIS METHODOLOGY (IES) USED: REVIEW OF THE BATCH RECORD FOUND NO ABNORMALITIES OR DEVIATIONS WHICH COULD HAVE LED TO THIS COMPLAINT. VISUAL INSPECTION OF RETENTION SAMPLES FOUND NO EVIDENCE OF ABNORMALITIES OR DEVIATIONS WHICH COULD HAVE LED TO THE REPORTED ISSUE. COMPLAINT SAMPLE EVALUATION: VISUAL EVALUATION OF THE SAMPLE FOUND THE GELATIN AND THROMBIN POUCH WERE CLOSED AND ORIGINALLY SEALED. THE OUTER PACKAGING OF THE UNIT (UNIT CARTON) WAS OBSERVED TO BE WET AND THE ORIGINAL SEAL WAS NOT INTACT. AN IDENTIFICATION OF THE SPECIFIC FAILURE MODE (MODES) AND OR MECHANISM (S) AND THE ASSOCIATED DEVICE COMPONENTS (INVOLVED): NO PRODUCT DEFECTS WERE IDENTIFIED AS THE RETURNED POUCHES WERE ORIGINALLY CLOSED AND SEALED. THE INVESTIGATION OF THE SAMPLE DID NOT REVEAL ANY DEVIATIONS. THE OUTER PACKAGING OF THE UNIT (UNIT CARTON) WAS OBSERVED TO BE WET. AN ASSIGNABLE ROOT CAUSE DUE TO A MANUFACTURING DEFECT WITH A BAXTER PROCESS COULD NOT BE DETERMINED AT THIS TIME. ANY CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NO MANUFACTURING DEFECT WAS IDENTIFIED FOR THIS COMPLAINT ISSUE. THE MOISTURE IN THE OUTER PACKAGING IS POSSIBLY A RESULT OF CUSTOMER USAGE, SHIPPING OR STORAGE; HOWEVER NO DEFINITIVE ROOT CAUSE HAS BEEN IDENTIFIED. WHAT ACTIONS HAS YOUR FIRM TAKEN TO ADDRESS THE PROBLEM. AS NO MANUFACTURING DEFECT WAS IDENTIFIED FOR THIS COMPLAINT ISSUE, NO FURTHER ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). BAXTER (B)(4) COMPLETED THE INVESTIGATION. VISUAL EVALUATION OF THE RETURNED SAMPLES INDICATED THAT THERE WAS ONE UNIT CARTON OF FLOSEAL WITH LOT#: VNY1N022-AA, AND THE GELATIN AND THROMBIN POUCH WERE FOUND ORIGINALLY SEALED, NO DEFECTS WERE OBSERVED. THE OUTER PACKAGING OF THE UNIT WAS WET. THE COMPLAINT WAS CONFIRMED. IT IS POSSIBLE THAT CUSTOMER USAGE OR STORAGE MAY HAVE CONTRIBUTED TO THIS COMPLAINT. IT CANNOT BE EXCLUDED THAT THE MOISTURE IN THE OUTER PACKAGING IS A RESULT OF THE SHIPPING OR STORAGE CONDITIONS. A BATCH REVIEW PERFORMED FOR THE REPORTED LOT DID NOT REVEAL ANY ABNORMALITIES OR DEVIATIONS WHICH COULD HAVE LED TO THE REPORTED ISSUE. ALL RELEASE/TESTING SPECIFICATIONS WERE MET. NO TREND WAS IDENTIFIED. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS ABOUT MOISTURE (CONDENSED WATER) IN OUTER PACKAGING. NO PATIENT OR USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46406 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - VIENNA VNY1N022

    Patients

    Seq Age Sex Outcome Treatment
    1