MAUDE Adverse Event Report: C. R. BARD, INC. STATLOCK CATHETER STABILIZATION DEVICE; HOLDER, URETERAL CATHETER

Model Number FOL0101

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Discomfort (2330)

Event Date 05/18/2020

Event Type  Injury  

Event Description

I use a foley catheter.It is held in place on my leg by a foley statlock catheter stabilization device, model fol0101.A plastic clasp holds the catheter tubing in place to prevent harm or pulling on the indwelling catheter.On numerous occasions the plastic clasp would not hold tight and have to be replaced.It is quite uncomfortable when that happens because the rubber tubing of the catheter is pulling on me.I called foley, inc.And got no answers.The continuous replacement of the stabilization device is time consuming and often requires my home health care provider to come to my home with a new one.This must be costing (b)(6) quite a bit unnecessarily.An online search showed that many patients are having the same problem which seems to happen about 50% of the time.Fda safety report id# (b)(4).

• Brand Name: STATLOCK CATHETER STABILIZATION DEVICE
• Type of Device: HOLDER, URETERAL CATHETER
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 10078436
• MDR Text Key: 191864790
• Report Number: MW5094615
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2023
• Device Model Number: FOL0101
• Device Lot Number: JUDZ2336
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 66