MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE; CATHETER, RETENTION TYPE, BALLOON

Model Number A303416A

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Rn inserted 16fr foley catheter in the usual fashion.Upon inflating the balloon with 10cc, fluid began to leak forcefully from the urethra.Upon tugging on the catheter to seat the balloon at the bottom of the bladder, the catheter came out about halfway.Rn then removed the catheter and found the balloon to be completely deflated.Rn then tested the balloon with another 10cc and fluid leaked from middle of the catheter without the balloon inflating.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 15258017
• MDR Text Key: 298210298
• Report Number: 15258017
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: (01)00801741073823
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A303416A
• Device Catalogue Number: A303416A
• Device Lot Number: PK7638367
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 71 KG