MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY; STATLOCK DEVICE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2023

Event Type  Injury  

Event Description

It was reported that the staff had concerns about the use of foley statlock devices to secure foley catheters.Unfortunately, they had seen significant patient discomfort and meatal or urethral tearing related to the use of this statlock.Improper placement of statlocks could cause significant discomfort and meatal or urethral injury to male patients.Because of their experience with these issues, would like to offer the following suggestions.Statlocks work well for people who move minimally such as patients who remain in bed.They also were useful when securing suprapubic tubes.With mobile patients, statlocks were usually placed while in the supine position, therefore it was necessary to check proper placement with the patient in all positions prior to discharge and have the patient sit, stand, walk and bend to make sure that there was no pulling at the end of the penis.Explained that meatal area should be checked daily to ensure that there was no erosion.Also, educate the patient how to release the statlock if discomfort or erosion was occurring.When patients contact urology complaining of discomfort from their foley, one of the questions they ask was whether they had a sticky thing on their leg.If yes, they tell them to release it, and this had at times resolved the discomfort issue.Then could they come to clinic for proper evaluation.Leg straps were preferred because they could be adjusted by the patient unlike statlocks that were stationary.Medical intervention was unknown.As per follow-up via email on 21mar2023, it was reported that the customer stated it really was not a statlock complaint as much as sharing their experience with the product.They shared some thoughts about the teaching and use of the product that could prevent injury.Unfortunately, they had seen erosions of the meatus and urethra of male patients from the device not used properly, and they were just trying to educate people on how to use them safely.Also stated, it might be a bit more instruction should be provided for their use in the packaging.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the staff had concerns about the use of foley statlock devices to secure foley catheters.Unfortunately, they had seen significant patient discomfort and meatal or urethral tearing related to the use of this statlock.Improper placement of statlocks could cause significant discomfort and meatal or urethral injury to male patients.Because of their experience with these issues, would like to offer the following suggestions.Statlocks work well for people who move minimally such as patients who remain in bed.They also were useful when securing suprapubic tubes.With mobile patients, statlocks were usually placed while in the supine position, therefore it was necessary to check proper placement with the patient in all positions prior to discharge and have the patient sit, stand, walk and bend to make sure that there was no pulling at the end of the penis.Explained that meatal area should be checked daily to ensure that there was no erosion.Also, educate the patient how to release the statlock if discomfort or erosion was occurring.When patients contact urology complaining of discomfort from their foley, one of the questions they ask was whether they had a sticky thing on their leg.If yes, they tell them to release it, and this had at times resolved the discomfort issue.Then could they come to clinic for proper evaluation.Leg straps were preferred because they could be adjusted by the patient unlike statlocks that were stationary.As per follow-up via email on 21mar2023, it was reported that the customer stated it really was not a statlock complaint as much as sharing their experience with the product.They shared some thoughts about the teaching and use of the product that could prevent injury.Unfortunately, they had seen erosions of the meatus and urethra of male patients from the device not used properly, and they were just trying to educate people on how to use them safely.Also stated, it might be a bit more instruction should be provided for their use in the packaging.It was unknown what medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "materials of construction are not biocompatible" it was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.Correction- f, h.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: STATLOCK SL FOLEY
• Type of Device: STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16643043
• MDR Text Key: 312299591
• Report Number: 1018233-2023-02156
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male