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

Catalog Number FOL0101

Device Problems Kinked (1339); Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that the statlock device for latex catheters would not close over the 16fr silver alloy coated silicone dover 605163ic, or the medline dynd141016 catheters that the patient used.The patient reported that the statlock would only close over the inflation port and alleged that this has caused the statlock device to rotate during use creating a kink in the catheter.

Manufacturer Narrative

Received 1 statlock stabilization device lot sample with 1 unused catheter.The reported issue was unconfirmed since the retainer performed as intended.Per visual inspection, the returned device was opened and marked as 2 including the pouch, foam pad and both skin protectant prep pad.The sample was visualized with the retainer in an open position and both liner tabs correctly folded and attached to the adhesive part of the foam pad.No damages were perceived during the inspection.Per functional evaluation, the sample was evaluated for the retainer's proper functionality with the returned catheter, which was noticed to have an unusual wider external diameter at the ¿y¿ as well as a membrane connecting the inflation port to the drainage port, conditions most of the 16 french catheters do not have.For bigger or wider catheters it is recommended to close the retainer only over the inflation port on the part of the retainer that lends the snuggest fit (which was done by customer).The retainer remained closed and was swiveled 360 degrees as specified.The statlock device is design to rotate 360 degrees for patients comfort as the clamp moves with him/her.To ensure proper placement; it must be on the anterior thigh and leaving only one inch of slack which is recommended for comfortable movement and will prevent catheter kinking.If there is too much slack in the catheter then the clamp may turn so much that it leads to kinking of the catheter.This issue is potentially a user-related factor.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state 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: 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.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 the statlock device for latex catheters would not close over the 16fr silver alloy coated silicone dover (b)(4), or the medline (b)(4) catheters that the patient used.The patient reported that the statlock would only close over the inflation port and alleged that this has caused the statlock device to rotate during use creating a kink in the catheter.

• Brand Name: SL FOLEY SWIVEL
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6957611
• MDR Text Key: 89774751
• Report Number: 1018233-2017-05329
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076091
• UDI-Public: (01)00801741076091
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: FOL0101
• Device Lot Number: JUBSF103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2017
• 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