BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL SYRINGE

    MDR report key: 2848672 · Received September 27, 2012

    Report

    Report Number
    3007056120-2012-00021
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Report Date
    September 11, 2012
    Manufacturer
    CHILDREN'S MEDICAL VENTURES
    Product Code
    FPD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). UPON REVIEW OF THE COMPLAINT RECORD IT IS CONCLUDED THAT THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER COULD NOT BE SUBSTANTIATED BECAUSE THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. NO PT HARM HAS BEEN REPORTED IN ASSOCIATION WITH THE ALLEGED COMPLAINT CONDITION. THE CUSTOMER HAS BEEN CONTACT AND ADD'L REQUESTS FOR THE RETURN OF THE PRODUCT HAVE BEEN MADE. DUE TO THE DEVICE NOT BEING RETURNED NO FURTHER INVESTIGATION ACTIVITY CAN BE CONDUCTED AT THIS TIME. A REVIEW OF THE COMPLAINT DATABASE FROM AUGUST 1, 2008 TO SEPTEMBER 1, 2012 REVEALED THAT NO OTHER ALLEGATIONS OF A SYRINGE CONTAINING A SHARP PLASTIC SHARD HAVE BEEN REPORTED. ALTHOUGH THE ALLEGED FAILURE COULD NOT BE SUBSTANTIATED, QUALITY ASSURANCE HAS CONCLUDED THAT BASED ON THE AVAILABLE INFO, THE REPORTED FAILURE HAS BEEN ANTICIPATED IN THE PRODUCT RISK ASSESSMENT AND THAT USE OF THE DEVICE DOES NOT EXCEED THE RESIDUAL RISK OF USING THE DEVICE WHEN ORIGINALLY RELEASED TO THE MARKET. IF THE DEVICE IS RETURNED FOR EVAL, A F/U REPORT WILL BE SUBMITTED TO INCLUDE THE CONCLUSIONS REACHED DURING THE MANUFACTURES INVESTIGATION.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) REC'D MEDWATCH (B)(4) REPORT DETAILING A PRODUCT ISSUE ASSOCIATED WITH A 60ML ORAL SYRINGE DEVICE PART NUMBER 107084. THIS INVESTIGATION HAS BEEN INITIATED DUE TO THE ALLEGATION OF THE FEEDING SYRINGE CONTAINING A SHARP SHARD OF PLASTIC. THE ASSOCIATED LOT NUMBER HAS BEEN REPORTED AS 85310. NO PT HARM HAS BEEN REPORTED, THE SYRINGE WAS NOT PUT INTO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL SYRINGE FPD CHILDREN'S MEDICAL VENTURES 1047084 85310

    Patients

    Seq Age Sex Outcome Treatment
    1