MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CATHETER, PERITONEAL

Model Number	30414-025
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Unopened penrose drain with holes or dry rot in the drain.

• Brand Name: CARDINAL HEALTH
• Common Device Name: CATHETER, PERITONEAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15787662
• Report Number: 15787662
• Device Sequence Number: 12199394
• Product Code: GBW
• UDI-Device Identifier: 10885425501809
• UDI-Public: (01)10885425501809(11)200702(17)250702(10)462703
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2022
• Report Date (Section F): 10/25/2022

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: 30414-025
• Device Catalogue Number: 30414-025
• Device Lot Number: 462703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/25/2022