MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK

Catalog Number FOL0102

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Itching Sensation (1943)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "statlock® foley stabilization device.Read carefully before use.Safety and efficacy considerations: single use only.Rx only.Sterile by ethylene oxide.Discard if package is opened or damaged.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.Latex free contents: package includes the statlock® device stabilization system and skin preparation pads.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 nonadherent 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: a.The statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.B.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.C.If showering/bathing, cover with plastic wrap or waterproof dressing.D.Conduct skin assessment prior to application and repeat daily per facility protocol.E.Use clinical judgment on the removal of the statlock® stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity.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.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.Emove 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." the device was not returned.

Event Description

It was reported that the patient followed the procedure videos for application, yet the statlock devices fell off after the second day of use.The patient attempted to use waterproof tape to secure the devices.The patient also reported itching.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• Type of Device: STATLOCK
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6811836
• MDR Text Key: 84347068
• Report Number: 1018233-2017-04389
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• 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: Patient
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2017
• 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