MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE ERASE SILICONE URINARY CATHETER ; CATHETER CARE TRAY

Device Problems Deflation Problem (1149); Flushing Problem (1252); Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528); No Flow (2991)

Patient Problem Urinary Tract Infection (2120)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

Since (b)(6) 2020, multiple (10) patient safety alerts have been reported by multiple clinical units, involving concerns with medline silicone urinary catheters.Summary of events include: on (b)(6): positive catheter associated urinary tract infection (cauti), (b)(6): leaking around catheter insertion site, (b)(6): catheter plugged, not draining, unable to flush; (b)(6): leaking from flush port, (b)(6): leaking at insertion site, balloon inflated correctly, (b)(6): unable to inflate properly, attempted removal, balloon unable to deflate, imaging revealed balloon in urethra.Balloon tubing had to be cut and balloon deflated through scrotum, (b)(6): insertion with no urine output and difficulty on insertion.Inserted latex catheter with no difficulty and urine output occurred; (b)(6): leaking at insertion site, (b)(6): leaking at insertion site, (b)(6), leaking at insertion site.Fda safety report id# (b)(4).

• Brand Name: MEDLINE ERASE SILICONE URINARY CATHETER
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10108794
• MDR Text Key: 193694268
• Report Number: MW5094778
• Device Sequence Number: 2
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/28/2020
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other