MAUDE Adverse Event Report: WILLY RUSCH GMBH RUSCH SILICONE 3-WAY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Lot Number NGFZ2375

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

Two 2 patients affected; 3-way catheters placed in operating room on (b)(6) 2022.Both incidents happened on (b)(6) 2022.First patient: patient was assisted to bedside commode.When patient assisted back to bed, it was noted that the 3-way foley catheter came out with fluid on the floor and the balloon was deflated.Balloon was checked and it was found to be leaking.Additional 3-way foley catheter was placed a few hours later.Rusch silicone 3-way catheter balloon (30cc balloon).Lot# ngfz2375.Second patient: patient assisted to chair when 3-way catheter fell out; 2nd incident where rusch silicone 3-way catheter balloon (30cc balloon).Lot#ngfz2375 was leaking.Fda safety report id# (b)(4).

• Brand Name: RUSCH SILICONE 3-WAY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): WILLY RUSCH GMBH
• MDR Report Key: 15282657
• MDR Text Key: 298597124
• Report Number: MW5111662
• Device Sequence Number: 2
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: NGFZ2375
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 91 KG