MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 8888505016

Device Problems Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

We found an argyle yankauer tip that had a hair in the pack.The pack was not opened.

• Brand Name: ARGYLE
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16643679
• MDR Text Key: 312332593
• Report Number: 16643679
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884527019946
• UDI-Public: (01)10884527019946(17)271130(10)2235417564
• 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: 02/27/2023

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 Model Number: 8888505016
• Device Catalogue Number: 8888505016
• Device Lot Number: 2235417564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1