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

Model Number 2D72PT75X

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2021

Event Type  malfunction  

Event 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
• Type of Device: SURGEONS GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11723549
• MDR Text Key: 247276704
• Report Number: 11723549
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380031953
• UDI-Public: (01)10885380031953
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2D72PT75X
• Device Catalogue Number: 2D72PT75X
• Device Lot Number: TS20100210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1