BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPAN TRANSYSTEM AMIES MEDIUM WITH CHARCOAL

    MDR report key: 4287489 · Received November 20, 2014

    Report

    Report Number
    3002444944-2014-00003
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 20, 2014
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JSL
    PMA / PMN Number
    K972449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF BATCH HISTORY RECORDS: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE BEFORE THE RELEASE ON THE MARKET ON THE SWABS OF THE PRODUCT CODE 114C. USE NUMBER PCX801: LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE ORIGINAL LOT, MANUFACTURED 2013, WAS COMPRISED OF (B)(4) UNITS, THIS IS THE FIRST NOTIFICATION RECEIVED FOR THIS SPECIFIC LOT. THE DEVICE WAS NOT RETURNED TO COPAN FOR EVALUATION. MECHANICAL TEST ON THE RETAINED SAMPLE FROM THE CLAIMED LOT HAS BEEN PERFORMED: ALL THE TESTED SWABS GAVE CONFORMING RESULTS. OUR INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTIONS OR DEFECTS IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, BASED ON: THE MEDICAL DESCRIPTION OF THE EVENT, THE PATIENT BEHAVIOR AFTER THE EVENT AND THE INTERNAL INVESTIGATION ON THE RETAINED SAMPLES, OUR HYPOTHESIS IS THAT THE TIP WAS ALREADY MISSING BEFORE THE SWAB WAS USED FOR SAMPLING. A REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT DOES NOT INDICATE A TREND FOR THIS TYPE OF ISSUE. COPAN WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). THE VERBAL REPORT FROM THE PHYSICIAN PROVIDED BY THE MEDICAL LABORATORY INDICATES THAT "CHILD WAS EXAMINED SITTING BESIDE MOTHER IN CHAIR. FLASHLIGHT EXAM NOTED THROAT SLIGHTLY RED; STUFFY NOSE. DECISION MADE TO CHECK FOR STREPT USING LABORATORY SWAB, CHILD APPEARED WELL; SITTING IN THE CHAIR; COMPLETELY COOPERATIVE. CHILD DID NOT STRUGGLE; NO NEED TO HOLD. PHYSICIAN REMOVED STICK FROM PACKAGE AS PER NORMAL PRACTICE; SWABS ARE STORED ON COUNTER IN BUCKET. INSERTED INTO MOUTH; NO TONGUE DEPRESSOR USED. SWABBED LEFT TONSIL. REMOVED STICK; TURNED TO GRAB PACKAGE TO INSERT STICK INTO TUBE: REALIZED NO TIP WAS STICK. TURNED BACK TO CHILD WHO REMAINED COMPLETELY STABLE. ASKED CHILD "ARE YOU OK" AND HE SAID "YES." PATIENT DIDN'T REPORT ANYTHING. WHEN ASKED "DID YOU SWALLOW IT?" HE WAS CONFUSED BY QUESTION AND REPLIED "MAYBE." PHYSICIAN IMMEDIATELY QUESTIONED HERSELF RE: WHAT HAPPENED TO THE TIP? DID WE LOSE IT? DID HE SWALLOW IT? LISTENED TO PATIENT'S CHEST - CLEAR. PATIENT CONTINUED TO BREATH AND TALK NORMALLY; SAT HAPPILY. MOM WAS NOT DISTRESSED. PHYSICIAN EXPLAINED SITUATION TO MOM; BOTH LOOKED AROUND CLOTHING AND AREA AND IN PACKAGE: NOT FOUND. PHYSICIAN GRABBED ANOTHER SWAB TO DETERMINE SIZE OF MISSING TIP. DETERMINED IT WAS COTTON AND PIECE OF SHAFT. PHYSICIAN SPOKE TO MOM RE: RISKS OF SWALLOWING FOREIGN BODY. DECISION MADE TO SEND PATIENT TO (B)(6) WITH EXPLANATORY NOTE. MOM TOOK SWAB WITH HER TO EMERGENCY DEPARTMENT. PRIOR TO LEAVING OFFICE, COMPLETED A QUICK STREPT TEST - PATIENT REMAINED COMPLETELY COOPERATIVE. QUICK STREPT NEGATIVE. PHYSICIAN APOLOGISED TO MOM; ACKNOWLEDGED THAT INCIDENT WOULD BE REPORTED. PROVIDED MOM WITH PHYSICIAN'S CELL PHONE NUMBER AND REQUESTED THAT MOM RETURN THE SWAB. THEN CALL (B)(4) TO REPORT INCIDENT. PATIENT WAS SEEN AT (B)(6); X-RAY DONE; NO CONCERNS NOTED. MOM REMAINS IN TOUCH WITH PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755263 COPAN TRANSYSTEM AMIES MEDIUM WITH CHARCOAL JSL COPAN ITALIA SPA 114C.USE FCX801

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention