MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED GLOVE SURGICAL PROTEXIS PI; SURGEON'S GLOVES

Model Number 2D72PT65X

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Because the complaint sample and photo are not available for evaluation, a review of the physical properties trending found tensile strength and cuff, palm, finger thickness were within our specification, therefore an exact root cause could not be determined for this case.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but we will continue to monitor the trend of this type of incident.

Event Description

It was reported that during an orthopedic surgery, the surgeon¿s glove tore causing him contact with the patient's blood which was positive for (b)(6).The surgeon performed immediate cleaning and disinfection of the skin area in contact with blood.Minimal delay in procedure.The surgeon did not require follow up lab testing or medications.No injury reported to the patient.No further issues reported from surgeon.

• Brand Name: GLOVE SURGICAL PROTEXIS PI
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10286067
• MDR Text Key: 202555591
• Report Number: 1423537-2020-00483
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380031939
• UDI-Public: 10885380031939
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2020

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: Health Professional
• Device Model Number: 2D72PT65X
• Device Catalogue Number: 2D72PT65X
• Device Lot Number: TS19090157
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other