BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL OB PACK IV 5

    MDR report key: 15414199 · Received September 13, 2022

    Report

    Report Number
    3005997949-2022-00002
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 15, 2022
    Report Date
    September 26, 2022
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    KKX
    UDI-DI
    30680651888410
    PMA / PMN Number
    K083234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT REPORTED IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THE LOT MET ALL MANUFACTURING PROCESS AND QUALITY SPECIFICATIONS PRIOR TO RELEASE. NO REWORK OR SPECIAL CONDITIONS WERE REPORTED. NO PICTURES OR PRODUCT SAMPLES WERE PROVIDED, THEREFORE THE SITE IS UNABLE TO FURTHER IDENTIFY THE ROOT CAUSE PER REPORTED EVENT. ALL INFORMATION REASONABLY KNOWN AS OF 24OCT2022 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT REPORTED IS NOT AVAILABLE FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2022 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    REPORTER INDICATES THAT WHILE UTILIZING O&M HALYARD SURGICAL OB PACK, THE QBL (QUANTITATIVE BLOOD LOSS) DRAPE DID NOT CONTAIN THE USUAL MEASURING COMPONENT. THE PATIENT HAD A RETAINED PLACENTA AND POSTPARTUM HEMORRHAGE. REPORTER INDICATES THAT AS A RESULT OF THE MISSING DRAPE MEASURING COMPONENT, THE PATIENT'S BLOOD LOSS WAS LIKELY UNDERESTIMATED UNTIL THEY HAD SYMPTOMATIC ANEMIA. PATIENT DID RECEIVE A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390862 SURGICAL OB PACK IV 5 SURGICAL DRAPES AND PACKS KKX O&M HALYARD, INC. 88841 AC2210907A 30680651888410

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other