BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 3888226 · Received April 17, 2014

    Report

    Report Number
    8020045-2014-00004
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    K08/0106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN INTERNAL AUDIT, WE HAVE REVIEWED OUR COMPLAINT DATABASE AND REALIZED THAT WE HAD MISSED REPORTING THIS NEAR INCIDENT TO THE FDA. AS WE HAVE NEVER SUPPLIED ELECTRODES OF THAT DESIGN (NEONATAL ELECTRODES WITH A FIXED LEAD) TO THE USE SO FAR, IT WAS INITIALLY DETERMINED THAT THE NEAR INCIDENT WAS NOT REPORTABLE. HOWEVER, THE PRODUCT IS COVERED UNDER AN EXISTING 510K AND WE THEREFORE FILE THIS REPORT. AN INVESTIGATION WAS PERFORMED TO DETERMINE THE LIKELIHOOD OF A RE-OCCURRENCE. FOR THIS PURPOSE RETAINED LOTS OF SAMPLES FROM EACH MONTH OF 2013 WERE EXAMINED. SOME OF THE LABELS DID NOT FULLY ADHERE TO THE ELECTRODES OVER THEIR ENTIRE SURFACE. HOWEVER, IN EACH CASE FORCE NEEDED TO BE APPLIED TO TEAR THE LABEL FROM THE ELECTRODE. THE NEAR INCIDENT WAS CLASSIFIED AS A SINGULAR EVENT WITH A VERY LOW REPEAT PROBABILITY. NO FIELD ACTION WAS INITIATED. IN ORDER TO IMPROVE THE DESIGN OF THE PRODUCT, THE SPECIFICATION OF THE LABEL HAS BEEN MODIFIED. EFFECTIVE (B)(6) 2014, A SOFT FOAM MATERIAL IS USED TO REPLACE THE PLASTIC FILM AS A LABEL ON ALL NEONATAL AND PEDIATRIC ELECTRODES WITH FIXED LEAD. THIS FOAM MATERIAL ADHERES AND CONFORMS SO WELL TO THE ELECTRODE AND THE LEAD THAT IT CANNOT BE SEPARATED FROM THE ELECTRODE.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED BY (B)(6) ABOUT A NEAR INCIDENT DURING THE USE OF A NEONATAL ECG ELECTRODE SET AT HOSPITAL (B)(6). THE ECG ELECTRODES (PD50-SF) WERE APPLIED TO A PREMATURE BABY (BORN IN THE (B)(6) WEEK OF PREGNANCY). A NURSE FOUND A DISC SHAPED ELEMENT OF ONE ELECTRODE (A PRINTED LABEL) IN THE MOUTH OF THE BABY. THIS CONSTITUTES A POTENTIAL SUFFOCATION HAZARD FOR THE BABY. NO FURTHER INFO ON THE BABY HAS BEEN DISCLOSED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235971 SKINTACT ECG ELECTRODE DRX LEONHARD LANG GMBH PD50-SF 30712-0762

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Other