MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROTEXIS; SURGEONS GLOVES

Model Number	2D72PT75X
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Two events have been reported with same issue.First event.Registered nurse (rn) put on a pair of the orange protexis pi sterile polyisoprene powder-free surgical gloves (size 7 1/2), and the cuff of the glove ripped halfway off on the right side.There was not very much pressure used in putting the glove on, much less than normal as this has happened with this type of glove in the past.(glove ref: (b)(4), lot: ts20100210, mfg: 2020-10-17 use by date: 2023-09-30).Second event.When rn opened a pair of orange protexis pi sterile polyisoprene powder-free surgical gloves (size 6 1/2, (b)(4), lot# ts20100108, use by date 2023-09-30), they ripped apart as rn was putting them on.We have had several of these [protexis pi surgical gloves] doing this.

• Brand Name: PROTEXIS
• Common Device Name: SURGEONS GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11723549
• Report Number: 11723549
• Device Sequence Number: 17130172
• Product Code: KGO
• UDI-Device Identifier: 10885380031953
• UDI-Public: (01)10885380031953
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2021
• Report Date (Section F): 04/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 2D72PT75X
• Device Catalogue Number: 2D72PT75X
• Device Lot Number: TS20100210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/15/2021