MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® I.C. COMPLETE CARE® TEMP SENSING FOLEY; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number A339516AM

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 10/11/2021

Event Type  malfunction  

Event Description

Seal is loose and foley easily comes apart from drainage tubing.Foley was in less than 48 hours and needed new foley insertion.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® I.C. COMPLETE CARE® TEMP SENSING FOLEY
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 13108587
• MDR Text Key: 282903248
• Report Number: 13108587
• Device Sequence Number: 1
• Product Code: MJC
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A339516AM
• Device Catalogue Number: A339516AM
• Device Lot Number: NGFP3671
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Race: White