BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 728 SW,760 ML W/028 ADAPTOR

    MDR report key: 9723199 · Received February 18, 2020

    Report

    Report Number
    1417411-2020-00007
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 22, 2020
    Report Date
    January 31, 2020
    Product Code
    OGG
    PMA / PMN Number
    K141214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). CORRECTED DATA: SECTION D.1.- BRAND NAME CORRECTED TO HUDSON AQUAPAK 728 SW,760 ML W/028 ADAPTOR. SECTION D.2.- COMMON DEVICE NAME CORRECTED TO HUMIDIFIER NEBULIZER KIT. SECTION D.2B.- PROCODE CORRECTED TO OGG. SECTION D.4.- CATALOG# CORRECTED TO 037-28. ONE EMPTY 037-00, 760 ML, WATER BOTTLE LOT 19F110 WAS RECEIVED FOR EVALUATION. NO ADAPTOR WAS RECEIVED FOR EVALUATION. THE WATER BOTTLE ARRIVED WITH BOTH PORTS PUNCTURED. THE FRONT NEBULIZER OUTLET PORT WAS PUNCTURED CLEANLY WITHOUT PORT INVERSION. THE TOP ADAPTOR PORT ON THE WATER BOTTLE WAS INVERTED SUCH THAT THE PORT DID NOT RUPTURE. THE NUMBER "1" WAS EMBOSSED IN THE PLASTIC OF THE BOTTOM OF THE WATER BOTTLE. HANDWRITING ON THE SIDE OF THE BOTTLE APPEARED TO BE IN BLACK MARKER INK AND READ, "32762". NO OTHER VISUAL DEFECTS OBSERVED. THE INVESTIGATOR TESTED THE SAMPLE BOTTLE'S ADAPTOR PORT USING AN UNRELATED LOT OF NEBULIZER ADAPTOR. THE TEST ADAPTOR THREADED ONTO AQUAPAK BOTTLE WITHOUT DIFFICULTY. UPON REMOVING THE TEST ADAPTOR , IT WAS OBSERVED THAT THE BOTTLE'S ADAPTOR PORT HAD PUNCTURED CLEANLY. EACH ADAPTOR LOT (74H1901564 AND 74H1900582) PACKAGED WITH BOTTLE LOT 19F110 HAD A CERTIFICATE OF COMPLIANCE ON FILE FROM THE SUPPLIER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE PRODUCT INSTRUCTIONS FOR USE STATE, "THREAD THE NEBULIZER ADAPTOR ONTO THE RESERVOIR AND TIGHTEN." AS NO ADAPTOR SAMPLE IS AVAILABLE FROM THE CUSTOMER, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT STAFF WERE UNABLE TO OR HAD DIFFICULTY PUNCTURING THE TOP OF THE BOTTLE. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT STAFF WERE UNABLE TO OR HAD DIFFICULTY PUNCTURING THE TOP OF THE BOTTLE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183084 HUDSON AQUAPAK 728 SW,760 ML W/028 ADAPTOR HUMIDIFIER NEBULIZER KIT OGG 19F110
    183085 HUDSON AQUAPAK 728 SW,760 ML W/028 ADAPTOR HUMIDIFIER NEBULIZER KIT OGG 19F110

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.