UPON RECEIPT OF THE REPORT, MAI INITIATED AN INTERNAL PRODUCT COMPLAINT, (B)(4). WE HAVE REVIEWED OUR COMPLAINT DATABASE, AND AT THIS TIME WE DO NOT HAVE ANY NOTABLE TRENDS FOR THIS ISSUE RELATED TO THE COMPONENT AS PERTAINS TO ANY CONVENIENCE KITS WHICH CONTAINS THIS STYLE ITEM. MAI INITIATED A VENDOR SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) AND SUPPLIED A COPY OF THE RECEIVED MEDWATCH TO THE SUPPLIER CAREFUSION ON 04/13/2016. CAREFUSION WAS PROVIDED CUSTOMER CONTACT INFORMATION FOR SAMPLE RETRIEVAL AND EVALUATION. AT THIS TIME, THEIR INVESTIGATION HAS NOT CONCLUDED.
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ON 04/05/2016, MEDICAL ACTION INDUSTRIES (MAI), AN OWENS & MINOR COMPANY, RECEIVED MEDWATCH (B)(4) STATING THAT A NURSE WAS CUT BY A SHARD PROTRUDING FROM CHLORAPREP SEPP APPLICATOR, REF: 260449, WHEN SHE WENT TO ACTIVATE THE APPLICATOR FOR AN IV START SKIN PREP PROCEDURE. THIS COMPONENT WAS ONE OF SEVERAL COMPONENTS WHICH ARE PACKAGED BY MAI MEDICAL ACTION INDUSTRIES IV START CONVENIENCE KIT, 267004. THE END-USER DID NOT INDICATE A KIT OR COMPONENT LOT NUMBER ASSOCIATED WITH THE PRODUCT. MAI HAS CONFIRMED WITH THE HOSPITAL THAT THE EMPLOYEE INVOLVED HAD THEIR WOUND APPROPRIATELY DRESSED AND CLEANED. THE HOSPITAL REPORTED THIS ISSUE AS A PRODUCT PROBLEM. THE CHLORAPREP SEPP APPLICATOR INVOLVED IN THIS INCIDENT IS MANUFACTURED BY CAREFUSION. THIS COMPONENT IN ITS ORIGINAL COMPONENT PACKAGING IS PACKAGED BY MAI WITH OTHER MEDICAL COMPONENTS TO PRODUCE MAI IV START CONVENIENCE KIT, 267004.