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

Catalog Number 2D72PT75X

Device Problems Material Puncture/Hole (1504); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

Event Description

During port placement resident noticed a large hole in top white glove stated to the surgical tech that a new glove was needed.The surgical tech stated that a large piece of residents glove was missing and started to look around surgical field to locate the missing piece.The surgeon was aware of the missing glove piece but sated that they were proceeding with the surgery.Before closing the incisions the surgeon took a look around the inside of the patients abdomen and stated that the missing piece was not there.The trash, bottoms of shoes, entire room, around patient, equipment and surgical field were searched for the missing glove piece and nothing was recovered.Patient was extubated and taken to recover in stable condition.

• Brand Name: PROTEXIS
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 222 (THAILAND) LIMITED; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7998752
• MDR Text Key: 124861016
• Report Number: 7998752
• Device Sequence Number: 1
• Product Code: KGO
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2D72PT75X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA