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

Model Number FOL0101

Device Problem Break (1069)

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

Event Date 08/04/2021

Event Type  Injury  

Event Description

Patient is a (b)(6) male with an indwelling urinary catheter since (b)(6) 2021.Patient uses a statlock catheter stabilization device (manufacturer c.R.Bard, inc.(b)(4)) which he receives from his urologist.Patient had catheter changed at urology clinic on (b)(6) 2021 with no issues and received the customary statlock supplies to use until his next catheter change.I am his daughter and have been caring for him since (b)(6) 2021 and am the reporter.To date, we have had no issues with the statlock holding the catheter in place; however, i have had to replace all statlock supplies received since the catheter change due to the catheter holder locking device not staying closed.Three of the four locking devices have opened on their own (this has not happened before).The device clicks to the closed position, appears to be secured and then when i check, the lock has opened.The patient is primarily sedentary.To keep the catheter in place i have used elastic bandage wrap and cloth tape to hold the locking device in place to prevent inadvertent injury.The product number is fol0101 and the lot/use by date of the devices used this week that i have retained are: judy2781/2022-11-28, jufp8111/2024-01-28, jufp8026/2024-01-28.I have the defective devices, but cannot attribute which lot was used that was defective.Fda safety report id # (b)(4).

• Brand Name: STATLOCK STABIITY DEVICE
• Type of Device: HOLDER, URETERAL CATHETER
• Manufacturer (Section D): C. R. BARD, INC.; covington GA
• MDR Report Key: 12307690
• MDR Text Key: 266368206
• Report Number: MW5103163
• Device Sequence Number: 2
• Product Code: EYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/08/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FOL0101
• Device Catalogue Number: FOL0101
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 76