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

Catalog Number 2D72PT80X

Device Problems Detachment Of Device Component (1104); Hole In Material (1293)

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

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

Cardinal health is proactively filing this.The customer did not provide information about the patient or any specifics about the event.The customer did provide the lot number, therefore the device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The customer did not provide the sample.They did provide a photo of the glove piece that was retrieved, but the photo was not enough for an investigation.Therefore an exact root cause could not be determined.We will continue to monitor complaints for any unfavorable trends, which might require further investigation.

Event Description

Holes in the gloves occurred during a case.A glove piece became detached and fell into a patient, the piece was retrieved.No additional information about the patient or about the event were provided.

• 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 ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6945971
• MDR Text Key: 90468343
• Report Number: 1423537-2017-00131
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 2D72PT80X
• Device Lot Number: TS1703P044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2017
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other