BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11625620 · Received April 6, 2021

    Report

    Report Number
    3004932373-2021-00171
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 24, 2021
    Report Date
    July 1, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD (270449 - 8264564) WAS REVIEWED, AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. CURRENT PROCESS FAILURE MODE AND EFFECTS ANALYSIS REFERS INCORRECT PLACEMENT OF FOAM OR INCORRECT GLUING OF FOAM AS A POSSIBLE PROCESS FAILURE MODE, BUT WITHOUT A RETURNED SAMPLE IT IS NOT POSSIBLE TO DETERMINE IF THIS IS THE ROOT CAUSE. HISTORICAL TREND HAS SHOWN THAT THIS FAILURE MODE MAY ALSO OCCUR DUE TO THE DESIGN WHEN MULTIPLE ACTIVATION OCCURS. INSTRUCTIONS FOR USE SPECIFY THAT TO ACTIVATE APPLICATOR IT NEEDS TO BE SQUEEZED GENTLY ¿ONLY ONCE¿. IF THE APPLICATOR WAS PINCHED SEVERAL TIMES THIS COULD BE THE PROBABLE CAUSE FOR THE FAILURE MODE. WE WILL CONTINUE TO TRACK AND TREND FOR THIS FAILURE MODE. AT THIS MOMENT, NO FURTHER ACTION WILL BE TAKEN SINCE A DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    MATERIAL NO.: 270449, BATCH NO.: 8264564. IT WAS REPORTED THAT TWO MEMBERS OF THE STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. PER COMPLAINT FORM: I SPOKE TO (B)(6) ON THE PHONE THEY ARE IN RADIOLOGY AND USED THE CHLORAPREP SEPP THAT IS PART OF THE ROCIALLE CANNULATION PACK THAT IS USED IN WALES. THEY HAVE USED THE PRODUCT FOR A LONG TIME BUT TWO MEMBERS OF STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. ALSO BELOW PLEASE SEE THE INITIAL COMMUNICATION SENT TO ME VIA THE PRODUCT MANAGER. CONTACT INFO OMITTED. BUSINESS UNIT: INFECTION PREVENTION . PRODUCT LINE: CHLORAPREP . ENQUIRY: A COUPLE OF MY STAFF AND CUT THEIR FINGERS RECENTLY USING CHLORAPREP SEPP 0.67ML. THIS COULD BE A BATCH ISSUE? BATCH NUMBER 8264564.

    Additional Manufacturer Narrative · 1

    (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ANNEX E- E1701 ABRASION. ANNEX F- F25 UNANTICIPATED ADVERSE DEVICE EFFECT. ANNEX A- A24- ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR PROBLEM.

    Description of Event or Problem · 1

    MATERIAL NO.: 270449, BATCH NO.: 8264564. IT WAS REPORTED THAT TWO MEMBERS OF THE STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. PER COMPLAINT FORM: I SPOKE TO HELEN ON THE PHONE THEY ARE IN RADIOLOGY AND USED THE CHLORAPREP SEPP THAT IS PART OF THE ROCIALLE CANNULATION PACK THAT IS USED IN WALES. THEY HAVE USED THE PRODUCT FOR A LONG TIME BUT TWO MEMBERS OF STAFF HAVE HAD A SHARPS INJURY DUE TO THE GLASS BREAKING THROUGH THE PLASTIC. ALSO BELOW PLEASE SEE THE INITIAL COMMUNICATION SENT TO ME VIA THE PRODUCT MANAGER. CONTACT INFO OMITTED. BUSINESS UNIT: INFECTION PREVENTION PRODUCT LINE: CHLORAPREP ENQUIRY: A COUPLE OF MY STAFF AND CUT THEIR FINGERS RECENTLY USING CHLORAPREP SEPP 0.67ML. THIS COULD BE A BATCH ISSUE? BATCH NUMBER 8264564.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514722 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 8264564

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other