BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 13534890 · Received February 15, 2022

    Report

    Report Number
    3004932373-2022-00049
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    February 3, 2022
    Report Date
    April 28, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE AND PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL EXAMINATION SHOWS GLASS PARTICLE(S) INSIDE THE OPENED PACKAGE WHICH VERIFIED THE REPORTED ISSUE. THE FOAM TIP WAS INSPECTED AND IT IS 100% WELDED ONTO THE APPLICATOR BODY. THE GLASS MIGHT HAVE OCCURRED DURING THE ASSEMBLY PROCESS WHICH INSERTS A GLASS AMPOULE INTO THE APPLICATOR BODY. THE EQUIPMENT HAS SENSORS TO DETECT THE AMPOULE PRESENCE AND SCRAP NON-CONFORMING APPLICATORS. A GLASS AMPOULE MAY HAVE BEEN PRE-ACTIVATED DURING ASSEMBLY AND GLASS PARTICLE(S) MAY HAVE LANDED ON A NEARBY APPLICATOR. THIS OCCURRENCE IS A RARE ANOMALY AND THIS IS THE FIRST SUCH OCCURRENCE ON THE AUTO 10.5 ML #2 ASSEMBLY EQUIPMENT DURING THE PAST 12-MONTH REVIEW. THIS FAILURE WILL BE CATEGORIZED AS AN ISOLATED EVENT. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 1305540 AND NO NON CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING OF THIS LOT. A TRAINING AWARENESS WAS GIVEN TO THE MANUFACTURING ASSOCIATES AND THE QA TECHNICIANS TO BE AWARE OF SUCH AN ISSUE AND TO CLEAN THE EQUIPMENT UPON OCCURRENCES WHEN IDENTIFIED. THIS WAS ALSO COMMUNICATED TO ALL MANUFACTURING ASSOCIATES, LEADS AND SUPERVISORS. NO FURTHER ACTION IS REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL# : 930700; BATCH#: 1305540. IT WAS REPORTED THAT THERE WERE SHARPS. WE WOULD LIKE TO FILE A SERIOUS QUALITY COMPLIANT ON ITEM (B)(4) 10.5ML CHLORAPREPS ON LOT NUMBER 1305540. WE FILED A PSN ON THIS INCIDENT. DURING A PROCEDURE YESTERDAY, A PATIENT COMPLAINED ABOUT SCRATCHING ON THE AREA THE CHLORAPREP WAS APPLIED. THE AREA WAS BLEEDING AND THE END USER FOUND GLASS SHARDS INSIDE THE PACKAGING. I¿VE ATTACHED A PICTURE. THE STOCK OF THIS LOT HAS BEEN SET ASIDE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE SHARPS VERBATIM: WE WOULD LIKE TO FILE A SERIOUS QUALITY COMPLIANT ON ITEM 170837A 10.5ML CHLORAPREPS ON LOT NUMBER 1305540. WE FILED A PSN ON THIS INCIDENT. DURING A PROCEDURE YESTERDAY, A PATIENT COMPLAINED ABOUT SCRATCHING ON THE AREA THE CHLORAPREP WAS APPLIED. THE AREA WAS BLEEDING AND THE END USER FOUND GLASS SHARDS INSIDE THE PACKAGING. I¿VE ATTACHED A PICTURE. THE STOCK OF THIS LOT HAS BEEN SET ASIDE. 17FEB2022 KINDLY NOTE THAT ONE FOLLOW UP ATTEMPT WAS PERFORMED FOR THIS CASE, BUT NO ANSWER WAS RECEIVED.IF ANY NEW INFORMATION WAS RECEIVED, WE WILL NOTIFY YOU. 13MAR2022:KINDLY NOTE THAT ONE FOLLOW-UP ATTEMPT WAS PERFORMED VIA PHONE (ON 14-FEB-2022 AND 17-FEB-2022) AND E-MAIL (ON 17-FEB-2022) FOR THE SERIOUS CASE (B)(4) (BD ID: (B)(4)). ON 17-FEB-2022, REPORTER¿S REPLY WAS RECEIVED IN WHICH THE NEW REPORTER WAS MENTIONED AND ON 22-FEB-2022, THE COMPLETED FUQ FORM WAS RECEIVED (SEE CORRESPONDENCES ATTACHED) AND THE NEW CASE VERSION WAS OPENED, I.E. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798240 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1305540

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other