BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBSTETRICAL PACK 070

    MDR report key: 13501908 · Received February 9, 2022

    Report

    Report Number
    1423537-2022-00719
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    January 13, 2022
    Report Date
    April 6, 2022
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OKV
    UDI-DI
    10885425501540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT BEING FILED SINCE NEW INFORMATION IS AVAILABLE FOLLOWING THE INITIAL REPORT/SUPPLEMENTAL REPORT WAS FILED. AN INVESTIGATION INTO THE REPORTED ISSUE WAS PERFORMED BY CARDINAL HEALTH BASED ON A PHOTO PROVIDED BY THE CUSTOMER. BASED ON THE REVIEW OF THE PHOTO, IT WAS CONFIRMED THAT THE INCORRECT SYRINGE WAS PLACED IN THE OBSTETRICS KIT 29540, HOWEVER A REVIEW OF THE WORKORDER/LOT NUMBER 528348 IT DOES NOT INDICATE THE INCORRECT COMPONENT WAS USED. IT IS POSSIBLE THAT AN INCORRECT LOT NUMBER WAS PROVIDED BY THE CUSTOMER FOR THIS REPORT THAT WOULD HAVE INCLUDED THE INCORRECT PRODUCT. THE PRODUCTION STAFF AT THE MANUFACTURING SITE WAS NOTIFIED TO REINFORCE MONITORING PROCESS REGARDING PROPER IDENTIFICATION OF MATERIALS TO AVOID PLACING THE CORRECT SYRINGE IN THE KIT. IT SHOULD ALSO BE NOTED THAT THE CLINICIAN CAN EASILY RECOGNIZE THAT A 50CC ASEPTO BULB SYRINGE IS NOT SIMILAR OR USED IN THE SAME MANNER AS THE EXPECTED 3-OUNCE EAR ULCER BULB SYRINGE. IT WAS ALSO NOTED THAT THE CLINICIAN SHOULD HAVE ACCESS TO ADDITIONAL EAR BULB SYRINGES WITHIN CLINICAL SETTING.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING FILED FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT THAT WAS SUBMITTED ON 2/9/2022 DUE TO THE INVESTIGATION FINDINGS ARE AVAILABLE. SAMPLE PICTURE WAS AVAILABLE AT THE TIME OF THE COMPLAINT INVESTIGATION FOR EVALUATION AND BASED ON REVIEW WE CAN SEE THE INCORRECT COMPONENT. THEREFORE, THE DEFECT HAS BEEN CONFIRMED. THE IMAGE QUERY, SPECIAL INSTRUCTIONS, PACK¿S CONFIGURATION BY THE DESIGN DEPARTMENT, ELECTRONIC DEVICE HISTORY RECORD (EDHR), AND BILL OF MATERIALS (BOM) WERE REVIEWED FOR COMPONENT PLACEMENT AND MATERIAL USAGE FOR WORK ORDER (B)(4). THE WORK ORDER¿S BILL OF MATERIALS (BOM) CONSISTED OF 19 COMPONENTS OF WHICH 1 WAS REPORTED FOR WRONG COMPONENT: THE COMPONENT WAS THE (B)(4). THIS WORK ORDER WAS MANUFACTURED ON 01/13/2022 IN LINES 173 AND 273. THE PRODUCTION TEAM PERFORMED 15 KITS OUT OF 636 KITS, EVERY #50 KIT LABEL WAS INSPECTED WITH NO DEFECTS FOUND. A QUALITY ASSURANCE INSPECTION WAS PERFORMED ON THE LABEL SHEET #1 FROM THIS ORDER WITH NO DEFECTS FOUND. THERE WERE NO REPORTS OF ANY DEVIATION OR NON-CONFORMANCE INVESTIGATIONS (NCI) GENERATED FOR THE WORK ORDER. KIT 29850 WAS BUILT USING (TRI-CELL, SMALL CELL, ETC.). ACCORDING TO THE BOM (BILL OF MATERIALS), THERE WERE NO REPORTS OF ANY SCRAP, RETURN TO STOCK (RTS), OR AN ADDITIONAL PICK GENERATED BY THE PRODUCTION TEAMS, THE RECORDED LOT NUMBER FOR COMPONENT B0935830 WAS BMDSAM01. THE STOCK LOCATION FOR THE COMPONENT WAS INSPECTED AND SHOWS THE COMPONENT AS BEING STAGED CORRECTLY WITH NO ISSUES FOUND. THE PRODUCTION TEAM¿S PREVIOUS WORK ORDER WAS REVIEWED TO ENSURE PROPER LINE CLEARANCE BETWEEN ORDERS; AND SHOWED NOTHING OUT OF THE ORDINARY THAT COULD HAVE CONTRIBUTED TO THE WRONG COMPONENT. THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE 3-OZ,W/SLIM TIP, BULB, COMPONENT (B)(4), FROM THE STERILE OBSTETRICAL PACK 29850, WAS NOT INCLUDED IN THE PACK. THE PACK INCLUDED AN ASEPTO SYRINGE AND THE PRODUCT COULD NOT ASPIRATE MECONIUM DURING BIRTH OF THE INFANT. THIS CAUSED THE INFANT TO ASPIRATE AND BE PLACED IN NICU FOR 9 DAYS. INFANT REQUIRED THE USE OF A NASOGASTRIC TUBE AND PARENTERAL NUTRITION (TPN) DUE TO FLUID RETENTION. PATIENT WAS DISCHARGED AND IS CURRENTLY AT HOME IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849463 OBSTETRICAL PACK 070 OBSTETRICAL KIT OKV MEX03 MEXICO-JUAREZ PRESOURCE 29850 528348 10885425501540

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Other