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

Model Number FOL0100

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

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 patient experienced constant infections since the foley catheter was placed and had urine retention issues.Explained patient that there were no other substrates in which foley catheter made from.Medically patient required a foley to be placed and physician felt the silicone foley catheter was the better one.Also stated that patient had urine remained in bladder and could have risked kidney damage and infections.Unfortunately, patient had no other alternative to foley use like intermittent catheters or other medical procedures.Per additional information via email on 30nov2021, it was reported that the foley statlock was placed in patient for 2 weeks without removal or replacement.After removal, patient developed a rash where the statlock placed.Per follow up via phone on 03dec2021, customer had a procedure and required an emergent foley, they removed the foley but failed to pass whatever they were to pass from the surgery and placed a new foley.Upon removal of the first foley, customer had rash and itching in the vaginal area.Also had rash where the statlock was placed on their thigh.At one time the statlock came unclipped and the hospital recommended them to add tape to secure it.Customer had several emergency department visits and suffered with urinary tract infection and yeast infection.They were being treated by a physician with antibiotics.The first catheter was in place from (b)(6) 2021 to (b)(6) 2021 and the second catheter was in place from (b)(6) 2021 to (b)(6) 2021.Customer did not have these issues prior to the use of the catheter.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause of this failure could be ¿inappropriate snap fit".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problem or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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 decrease 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 under surface 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient experienced constant infections since the foley catheter was placed and had urine retention issues.Explained patient that there were no other substrates in which foley catheter made from.Medically patient required a foley to be placed and physician felt the silicone foley catheter was the better one.Also stated that patient had urine remained in bladder and could have risked kidney damage and infections.Unfortunately, patient had no other alternative to foley use like intermittent catheters or other medical procedures.Per additional information via email on 30nov2021, it was reported that the foley statlock was placed in patient for 2 weeks without removal or replacement.After removal, patient developed a rash where the statlock placed.Per follow up via phone on 03dec2021, customer had a procedure and required an emergent foley, they removed the foley but failed to pass whatever they were to pass from the surgery and placed a new foley.Upon removal of the first foley, customer had rash and itching in the vaginal area.Also had rash where the statlock was placed on their thigh.At one time the statlock came unclipped and the hospital recommended them to add tape to secure it.Customer had several emergency department visits and suffered with urinary tract infection and yeast infection.They were being treated by a physician with antibiotics.The first catheter was in place from (b)(6) 2021 to (b)(6) 2021 and the second catheter was in place from (b)(6) 2021 to (b)(6) 2021.Customer did not have these issues prior to the use of the catheter.

• 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
• 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: 13018092
• MDR Text Key: 285619211
• Report Number: 1018233-2021-08139
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0100
• Device Catalogue Number: FOL0100
• Device Lot Number: JUFU2615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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