BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OB DELIVERY PK

    MDR report key: 778604 · Received October 30, 2006

    Report

    Report Number
    1423395-2006-00011
    Event Type
    Malfunction
    Date Received
    October 30, 2006
    Report Date
    October 18, 2006
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KCB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EAR/ULCER BULB SYRINGES ARE NOT AVAILABLE FOR EVALUATION. THIS ITEM IS MADE BY AMSINO FOR MEDLINE AND ADDED TO THE OB DELIVERY PACKS.

    Description of Event or Problem · 1

    THE EAR / ULCER BULB SYRINGES REPORTEDLY DO NOT RE-INFLATE AFTER COMPRESSION RESULTING IN THE INABILITY TO SUCTION INFANT AIRWAYS AT THE TIME OF DELIVERY. REPORT SOURCE STATES THAT THIS HAS OCCURRED APPROXIMATELY 4 TIMES. THE INFANTS HAVE NOT EXPERIENCED ANY ADVERSE EFFECTS AS STAFF WAS ABLE TO QUICKLY OBTAIN A FUNCTIONING SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OB DELIVERY PK EAR/ULCER BULB SYRINGE IN SURGICAL PACK KCB MEDLINE INDUSTRIES, INC. DYNJ16715 06AD2092

    Patients

    Seq Age Sex Outcome Treatment
    1 *