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

Model Number A947316

Patient Problem Insufficient Information (4580)

Event Date 01/19/2024

Event Type  malfunction  

Event Description

After putting a foley in this patient, it was noted that the foley bag was locked at the drainage spout.When the nurse attempted to unclamp it, she was able to unclamp, however no drainage came out.She realized that the rubber drainage connector was still bent.She pulled on it and part of the backside of the drainage bag came with it.The drainage spout seemed to be glued to the backside of the foley bag and that is why it was clamped.Rn (registered nurse) put tap on it to slow the leak while we changed it out.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 18613217
• MDR Text Key: 334202797
• Report Number: 18613217
• Device Sequence Number: 1
• Product Code: EZL
• 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: 01/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A947316
• Device Catalogue Number: A947316
• Device Lot Number: NGHX0626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White