MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK DEVICE

Model Number FOL0102

Device Problem Biocompatibility (2886)

Patient Problems Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Irritability (2421)

Event Date 05/06/2021

Event Type  Injury  

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 issues the patient had with the statlock devices was causing the patient to have a urinary tract infection.It was unknown what medical intervention was provided for urinary tract infection.

Event Description

It was reported that the issues the patient had with the statlock devices was causing the patient to have a urinary tract infection.Per follow-up via call on 22jun2021, the customer had a bad allergic reaction to the adhesive on the statlocks and stated that the customer had a history of infections/urinary tract infection.The infection being reported for the event was located on the thigh where the statlock was placed.Leg would get red, swollen, and painful.The customer went to emergency department once with it, and they advised to stop using the statlock.The customer also reached the physician and the physician prescribed hydrocortisone 2.5%, then the issue was resolved.Now the customer secures the leg bag in place with a special wrapping cloth and gauze.It was stated that the customer does not use the statlock any longer.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials of construction are not biocompatible¿.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 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: 1.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.2.Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock® device.3.Minimize catheter manipulation during application and removal of the statlock® device.4.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 1.Place foley catheter into retainer.Directional arrow should point towards catheter tip, and balloon inflation arm should be next to the clamp hinge.2.Close lid, being careful to avoid pinching the catheter.3.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.4.After placing the statlock® stabilization device off to the side, cleanse and degrease the securement site with alcohol per hospital policy.Let skin dry.5.Apply skin protectant, in direction of hair growth, to area larger than securement site.Allow to dry completely (10-15 seconds).6.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 7.Align the statlock® stabilization device over securement site leaving 1 inch of catheter slack.Make sure leg is fully extended.8.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 1.Open retainer by pressing release button with thumb, then lift to open.2.Remove foley catheter from the statlock® device.Dissolve 3.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." h11: section a through f - the information provided by bd 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 bd.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• Type of Device: STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11905868
• MDR Text Key: 253543822
• Report Number: 1018233-2021-03123
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention