MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP PENROSE DRAINS STERILE LATEX; SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE

Catalog Number DYND50422

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

The drains are unopened and have perforations/holes in the drain.They appear to have dry rot.

• Brand Name: PENROSE DRAINS STERILE LATEX
• Type of Device: SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; one medline place; mudelein IL 60060 4486
• MDR Report Key: 15770367
• MDR Text Key: 303408778
• Report Number: 15770367
• Device Sequence Number: 1
• Product Code: NNZ
• 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 Catalogue Number: DYND50422
• Device Lot Number: 6051901002
• 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: 11/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1