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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH PROTEXIS PI BLUE WITH NEU-THERA, SIZE 7.5; STERILE GLOVES

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CARDINAL HEALTH PROTEXIS PI BLUE WITH NEU-THERA, SIZE 7.5; STERILE GLOVES Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2015
Event Type  malfunction  
Event Description
Sterile gloves tear easily during donning for surgical procedure.Potential risk for breach in asepsis and foreign body in surgical field.
 
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Brand Name
PROTEXIS PI BLUE WITH NEU-THERA, SIZE 7.5
Type of Device
STERILE GLOVES
Manufacturer (Section D)
CARDINAL HEALTH
MDR Report Key5243486
MDR Text Key31982687
Report NumberMW5058021
Device Sequence Number1
Product Code KGO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/18/2015
Type of Device Usage N
Patient Sequence Number1
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