MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL, 3-WAY SILICONE, TRICOT; STATLOCK DEVICE

Model Number FOL0105

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to "inappropriate snap fit".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "statlock¿ foley stabilization device.Read carefully before use.Safety and efficacy considerations: single use.Do not alter the statlock¿ device or components.Procedure must be performed by trained personnel with knowledge of anatomical landmarks, safe technique and potential complications.Contents: package includes the statlock¿ device stabilization system and skin preparation pad.Indications for use: the statlock¿ device is a stabilization device for compatible catheters.Contraindications: known tape or adhesive allergies.Warnings and precautions: do not use the statlock¿ device where loss of adherence could occur, such as with a confused patient, diaphoretic or non-adherent skin, or when the access device is not monitored daily.Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock¿ device.Minimize catheter manipulation during application and removal of the statlock¿ device.Daily maintenance: the statlock¿ device should be assessed daily and changed when clinically indicated, at least every seven days.If pad becomes soiled, wash with soap/water, saline or hydrogen peroxide.Do not use alcohol or prepackaged bathing systems, which could lead to early lifting.If showering/bathing, cover with plastic wrap or waterproof dressing.Conduct skin assessment prior to application and repeat daily per facility protocol.Use clinical judgment on the removal of the statlock¿ stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity.The statlock¿ stabilization device should be monitored daily and replaced when clinically indicated, at least every 7 days.The catheter insertion site should be treated per local policy recommendations.The statlock¿ device is contraindicated on patients with known tape and adhesive allergies.Alcohol and acetone may weaken the adhesive bond between the statlock¿ device pad and the skin.Care should be taken when using these solutions while performing catheter site care.Please consult product inserts and labels for any indications, contraindications, hazards, warnings, cautions and directions for use.For additional information on the statlock¿ foley stabilization device, please call your local bard representative.Instructions for use.Foley.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.Place and peel.Align the statlock¿ stabilization device over securement site leaving 1 inch of catheter slack.Make sure leg is fully extended.While holding the retainer to keep the pad in place, peel away paper backing, one side at a time and place tension-free on skin.Removal technique.Disengage.Open retainer by pressing release button with thumb, then lift to open.Remove foley catheter from the statlock¿ device.Dissolve.Wipe the edge of the pad using at least 5-6 alcohol pads until a corner lifts.Then continue to stroke undersurface of pad with alcohol to dissolve adhesive pad away from skin.Do not pull or force pad to remove.".

Event Description

It was reported that there was an unknown event.Per follow up via phone on (b)(6) 2020, it was stated that the clip of the statlock was popping off during use.

• Brand Name: SL FOLEY SWIVEL, 3-WAY SILICONE, TRICOT
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11087571
• MDR Text Key: 228350132
• Report Number: 1018233-2020-22088
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076145
• UDI-Public: (01)00801741076145
• 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: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0105
• Device Catalogue Number: FOL0105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• 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