BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC PACK (LADCA)144

    MDR report key: 9722862 · Received February 18, 2020

    Report

    Report Number
    1423537-2020-00418
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    January 1, 1980
    Report Date
    March 11, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    LRO
    UDI-DI
    10885425914005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL MDR IS BEING FILED BASED ON NEW INFORMATION RECEIVED FROM THE CUSTOMER FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT SUBMITTED ON 2/18/2020. ALLEGEDLY, A PATIENT HAD A LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2019. (B)(6) 2019 PATIENT PRESENTED TO AN OUTSIDE HOSPITAL WITH LOW GRADE FEVER AND SEVERE ABDOMINAL PAIN REQUIRING PERCUTANEOUS DRAINING OF 3 CM ABSCESS BY INTERVENTIONAL RADIOLOGY. (B)(6) 2019 IV ANTIBIOTICS INITIATED. (B)(6) 202019 DISCHARGED ON ORAL AUGMENTIN 875 MG THREE TIMES A DAY FOR 10 DAYS. NO FURTHER VISITS DOCUMENTED AFTER (B)(6) 202019. PATIENT WAS A 72 YO FEMALE, 183LB, NO FURTHER INFORMATION PROVIDED. THE KIT THAT WAS REPORTED TO CARDINAL HEALTH FOR THIS INCIDENT CONTAINS TWO GOWNS MANUFACTURED BY TWO DIFFERENT SUPPLIERS. SUPPLIER A IS (B)(4): BASED ON SUPPLIER INVESTIGATION FOR 9545NCC GOWN,SURGICAL,ASTOUND,X-LARGE,, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. NO SAMPLE WAS AVAILABLE FOR INVESTIGATION. SUPPLIER REVIEWED THEIR ENVIRONMENT CONTROL, TEMPERATURE/HUMIDITY, DIFFERENTIAL PRESSURE, AIR EXCHANGE TIME, PARTICLE, SETTLING MICROBE, PLANKTONIC BACTERIA AND SURFACE MICROORGANISMS MONITOR/TEST RECORD FROM (B)(6) 2019, ALL WITHIN THE SPECIFICATION. THERE IS NO ABNORMALITY FOUND. ACCORDING TO THEIR PRODUCTION ENVIRONMENT CONTROL PROCEDURE, EACH WORKSHOP SHALL DO THE ROUTINE DAILY CLEAN AND COMPREHENSIVE CLEAN ONCE OR TWICE A WEEK. FROM THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THERE IS NO ACTION TAKEN AT THIS TIME, BUT SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT. SUPPLIER B IS (B)(4): AT THE TIME OF THIS INVESTIGATION NO SAMPLE OR LOT NUMBER WERE PROVIDED FOR 90370NBA, GOWN,SURGICAL,W/TOWEL,X-LARGE,UNREINF,WRAPPED,NS. MANY ATTEMPTS WERE MADE TO RETRIEVE INVESTIGATION RESULTS FROM THE SUPPLIER, (B)(4), HOWEVER WE HAVE LEARNED THEY HAVE DE-LISTED THEIR FDA REGISTRATION AND THEY ARE NO LONGER IN BUSINESS SINCE JANUARY 2020. AS SUCH, WE DO NOT EXPECT TO RECEIVE ANY FEEDBACK OR INVESTIGATION RESULTS FROM THE SUPPLIER. CARDINAL HEALTH IS NO LONGER DOING BUSINESS WITH THIS SUPPLIER. CARDINAL HEALTH HAS INITIATED A FORMAL RECALL (EVENT #: (B)(4)) TO THE FDA OF CERTAIN CARDINAL HEALTH CONVENIENCE KITS THAT CONTAINED THE GOWNS MANUFACTURED BY THE SUPPLIER (B)(4). NO FURTHER ACTION WILL BE TAKEN AT HIS TIME, BUT WE WILL CONTINUE TO MONITOR OUR COMPLAINT DATABASE FOR ANY SIMILAR REPORTS.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE SEEN A SPIKE IN THEIR INFECTION RATES IN THE OPERATING ROOM OVER THE LAST TWO MONTHS. THIS CASE USED A CARDINAL HEALTH LAPAROSCOPIC PACK SLC2DLADCB THAT CONTAINED A LEVEL 3 SURGICAL GOWN. THE EXACT PROCEDURE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. THE PROCEDURE EITHER WAS PERFORMED PRIOR TO THE HOLD AND RECALL NOTICE(S) THAT WERE PROVIDED TO CUSTOMERS BEGINNING ON (B)(6) 2020 OR THEREAFTER. NO SAMPLE WAS AVAILABLE FOR EVALUATION AND A WORK ORDER/LOT NUMBER WAS NOT PROVIDED FOR THE KIT, THEREFORE, WE ARE UNABLE TO CONFIRM THAT THE GOWN IN THE KIT WAS PART OF THE RECALL ISSUED BY CARDINAL HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186176 LAPAROSCOPIC PACK (LADCA)144 GENERAL SURGERY TRAY (KIT) LRO MEX03 MEXICO-JUAREZ PRESOURCE SLC2DLADCB UNKNOWN 10885425914005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other