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

Model Number 2D7202I

Device Problem Failure to Clean Adequately (4048)

Patient Problem Unspecified Infection (1930)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Trending analysis for the past 12 months indicated this is the first event for this defect.The device history record for lot number ts20030001 was reviewed and no discrepancies were observed.The lot was inspected and released in compliance with all requirements.A review of defect photos that were provided by the customer found dark yellow color on the cuff fold area.The product is not re-sterilized by cardinal health.Due to non-availability of sample, the reported failure could not be confirmed.The exact root cause could not be determined at this time.We will continue to monitor the complaints for any unfavorable trends, which might require further investigation and action plan.

Event Description

Based on information received from the customer the ophthalmology found the color of the gloves are darker than before especially in the cuff region when performing an operation for glaucoma.The customer alleged unused gloves would be re-sterilized by cardinal health.Allegedly the eyes of three patients got infection after the surgery.The doctor gave anti- inflammatory eye drops to the patients.They are all recovered now.

Manufacturer Narrative

The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The returned sample was evaluated by visual inspection observed darker color on cuff at fold area, this product is made by natural latex color which is sensitive to uv and light that may result darker color.The color change of product is cosmetic and does not have an impact to product safety and feature.The product is not re-sterilized by cardinal health.We will continue to monitor the complaints for any unfavorable trends, which might require further investigation and action plan.

• Brand Name: GLOVE SURGICAL TRIFLEX CUSTOM
• 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
• MDR Report Key: 10453420
• MDR Text Key: 204357004
• Report Number: 1423537-2020-00501
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2D7202I
• Device Catalogue Number: 2D7202I
• Device Lot Number: TS20030001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/02/2020
• Supplement Dates FDA Received: 10/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other