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

Device Problem Use of Device Problem (1670)

Patient Problem Erosion (1750)

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.Per follow-up via email on 21mar, 2023, 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 investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

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.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 confirmed as use related because the patients did not used the device properly.A potential root cause for this failure could be "user deviation from instructions for use/ lack of understanding for properly maintaining statlock device".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.The dhr review is not required as the event is use related.Based on the results of investigation, no additional actions are needed.The instructions for use were found adequate and state the following: "daily maintenance: conduct skin assessment prior to application and repeat daily per facility protocol.Removal technique: disengage: open retainer by pressing release button with thumb, then lift to open.Remove foley catheter from the statlock® device.Do not pull or force pad to remove.Application technique prep: place foley catheter into retainer.Directional arrow should point towards catheter tip, and balloon inflation arm should be next to the clamp hinge.Close lid, being careful to avoid pinching the catheter.Identify securement site by laying the device retainer on the front of the thigh, leaving 1 inch of catheter slack between insertion site and the statlock® device retainer.After placing the statlock® stabilization device off to the side, cleanse and degrease the securement site with alcohol per hospital policy.Let skin dry.Apply skin protectant, in direction of hair growth, to area larger than securement site.Allow to dry completely (10-15 seconds).Using permanent marker, write initials and date of application on the statlock® device anchor pad.Note: always secure catheter into the statlock® device retainer before applying adhesive pad on skin." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text: the device was not returned.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN 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: 16672861
• MDR Text Key: 312604819
• Report Number: 1018233-2023-02272
• 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: 05/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/13/2023
• Supplement Dates FDA Received: 05/18/2023
• 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