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

Catalog Number FOL0100

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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 patient had an infection on skin because of the statlock.No medical intervention reported.

Manufacturer Narrative

The reported event could not be confirmed.It was unknown whether the device had met specifications due to no sample was returned for evaluation.A potential failure mode could be ¿materials of construction selected are not biocompatible¿ with a potential root cause of ¿materials of construction are not biocompatible or inadequate biological evaluation¿.This failure falls in a quad 2 risk region and based on this information the risk is moderate.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: ¿released: statlock® foley stabilization device.Read carefully before use.Safety and efficacy considerations: single use.Caution: federal (u.S.A.) law restricts this device.To sale by or on the order of a physician.Sterilized using ethylene oxide.Sterile unless package is opened or damaged, except for any individually packaged components within the pouch which are not labeled as sterile.These components are not terminally sterilized.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.© copyright 2006-2017 c.R.Bard, inc.Bard and statlock are trademarks and/or registered trademarks of c.R.Bard, inc.Protected by domestic and foreign patents and patents pending.Pk2405301 05/17.Manufacturer: c.R.Bard, inc.Covington, ga 30014 usa.800-526-4455, www.Bardmedical.Com.Assembled in mexico.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." 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.

Event Description

It was reported that the patient had an infection on skin because of the statlock.Medical intervention is unknown.

• Brand Name: SL FOLEY SWIVEL SILICONE 25BX
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10126609
• MDR Text Key: 194294974
• Report Number: 1018233-2020-03652
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: FOL0100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other