MAUDE Adverse Event Report: BARD SDN., BHD. SURESTEP FOLEY TRAY SYSTEM 16 FR; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number A947316

Device Problems Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 05/24/2022

Event Type  Injury  

Event Description

In process of discontinuing foley catheter and noticed much resistance even though full 10 ml "ns" removed from balloon.Tried to remove more incase over filled.Much resistance provided pain and slight bloody drainage from pt's urethra.Upon removal noticed deformity of catheter tubing in the tip where the balloon was ridged and diameter thickness significantly more that the rest of tubing causing resistance when attempting to smoothly remove tubing from urethra, suspect minor urethral trauma due to visible bloody drainage.Sample saved pt's nurse and nursing supervisor made aware.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM 16 FR
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): BARD SDN., BHD.
• MDR Report Key: 14653404
• MDR Text Key: 293836763
• Report Number: MW5110228
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: A947316
• Device Lot Number: NGGP3777
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BUSPIRONE 10 MG BID ; LITHIUM 300MG QAM
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White