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

Model Number 30414-025

Device Problems Material Disintegration (1177); Device Damaged Prior to Use (2284)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Unopened penrose drain with holes or dry rot in the drain.

• Brand Name: CARDINAL HEALTH
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15787662
• MDR Text Key: 303557126
• Report Number: 15787662
• Device Sequence Number: 1
• Product Code: GBW
• UDI-Device Identifier: 10885425501809
• UDI-Public: (01)10885425501809(11)200702(17)250702(10)462703
• 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: 10/25/2022

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
• Date Report Sent to FDA: 10/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1