MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; NON-SURGICAL ISOLATION GOWN

Model Number 2101PG

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 05/26/2021

Event Type  malfunction  

Event Description

Presumed human hair found in multiple packages of gowns.Manufacturer response for isolation gown, isolation gown - x-large (per site reporter): they requested pictures of the defect and have forwarded it to their quality team.Multiple other packs found with hair between by the end of may.Pictures sent to the representative, who denies any other similar reports.

• Brand Name: CARDINAL HEALTH
• Type of Device: NON-SURGICAL ISOLATION GOWN
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12142007
• MDR Text Key: 260712390
• Report Number: 12142007
• Device Sequence Number: 1
• Product Code: OEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2021

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 Operator: No Information
• Device Model Number: 2101PG
• Device Catalogue Number: 2101PG
• Device Lot Number: 20KQNNA004
• 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: 07/06/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1