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

Catalog Number 2D72LE75

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Complaint forwarded to plant for investigation, and the sample is being retrieved.Will file follow up report once their investigation is completed.

Event Description

The surgeon noticed at the end of an ophthalmologic procedure that the middle finger of the glove was torn.On (b)(6) 2016 it was learned that prophylactic antibiotic treatment was applied to the patient at the end of the case because of the torn glove.No other information was provided about the patient as the customer considered this information confidential.

Manufacturer Narrative

This is a follow up report based on sample receipt.The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Historical trending was done.The returned sample received was a "representative" glove sample.Evaluation was done by physical properties testing, which found the tensile strength and thickness testing were within specification. therefore an exact root cause could not be determined.We will continue to monitor complaints for any unfavorable trends, which might require further investigation.

• Brand Name: CARDINAL GLOVES
• 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: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6106250
• MDR Text Key: 60551169
• Report Number: 1423537-2016-00059
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380124341
• UDI-Public: (01)10885380124341
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 2D72LE75
• Device Lot Number: TS16050063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other