MAI RECEIVED THE MEDWATCH (B)(4) REPORT DETAILING PATIENT INJURY ON (B)(6) 2016. UPON RECEIPT, MAI FOLLOWED UP WITH THE HOSPITAL FOR A COMPLETE DESCRIPTION OF INCIDENT AND DETAILS RELATED TO THE PATIENT WELL-BEING AND DEVICES INVOLVED. THE HOSPITAL INFORMED MAI THAT THE APPLICATOR INVOLVED IN THE INCIDENT WAS RETURNED TO THE COMPONENT MANUFACTURER CAREFUSION. CAREFUSION REPORTS TO MAI THAT IT HAS CONDUCTED AN INVESTIGATION OF THE APPLICATOR. THE INVESTIGATION INDICATED THERE WAS NO PRESENCE OR EVIDENCE OF ANY FOREIGN MATERIAL AND THAT THERE WAS NO ISSUES OBSERVED. THE INSIDE CAVITY OF THE PRODUCT WAS OPENED AND THERE WAS NO DAMAGE FOUND. THE PRODUCTION RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE NOTED. NO ROOT CAUSE WAS ABLE TO BE CONFIRMED AND NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED RELATED TO THIS ISSUE.
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Patient 1
ON 01/05/2016, MEDICAL ACTION INDUSTRIES (MAI), (B)(4), RECEIVED MEDWATCH (B)(4) WHICH INDICATED A PATIENT SUFFERED AN INJURY ASSOCIATED WITH THE USE OF CHLORAPREP. A NURSE AT (B)(6) HOSPITAL REPORTED USING THE CHLORAPREP TO PREP A PATIENT FOR IV INSERTION WHEN SHE NOTED TWO LINEAR ABRASIONS TO THE PATIENT'S RIGHT ANTECUBITAL AREA AS A RESULT OF USING THE CHLORAPREP. THE HOSPITAL RETURNED THE AFFECTED COMPONENT TO CAREFUSION (THE COMPONENT MANUFACTURER) FOR EVALUATION AND INVESTIGATION. THE AREA WAS CLEANED AND GAUZE BANDAGE APPLIED BY NURSE AT THE TIME OF THE INCIDENT. THE CHLORAPREP FREPP 1.5ML APPLICATOR INVOLVED (LOT: 88663) WAS MANUFACTURED BY CAREFUSION. THE COMPONENT WAS INCLUDED IN A MAI-MANUFACTURED CONVENIENCE KIT 267014, IV START KIT.