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

Model Number FOL0101

Device Problem Disconnection (1171)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

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 statlock catheter stabilization device was not staying closed.Three of the locking devices had opened on their own.The device clicked to the closed position, appeared to be secured and when the customer checked, the lock had opened.The patient was primarily sedentary.Also to keep the catheter in place, the customer had used elastic bandage wrap and cloth tape to hold the locking device in place to prevent inadvertent injury.The lots used were judy2781, jufp8111 and jufp8026.But customer cannot attribute which lot was used that was defective.Per additional information via email on 26 aug 2021, the customer had new statlock device that was working as intended, when initially placed on patient, but it had been unlocking throughout the day which caused discomfort when the catheter pulled on.Customer took secondary measures to keep the indwelling catheter secured to the leg so it did not cause additional injury.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to inappropriate snap fit.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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 or 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 to 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 to 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 statlock catheter stabilization device was not staying closed.Three of the four locking devices had opened on their own.The device was clicked to the closed position which appeared to be secured and during the customer check the lock was opened.The patient was primarily sedentary and to keep the catheter in place the customer used elastic bandage wrap and cloth tape to hold the locking device in place to prevent inadvertent injury.The lots used to be judy2781 jufp8111 jufp8026 but the customer could not attribute which lot was defective.Per additional information received via email on 26aug2021 the customer had a new statlock device which was working as intended when initially placed on a patient.It was noted that due to the unlocking of the device throughout the day which caused discomfort to the patient when the catheter pulls on.The customer takes secondary measures to keep the indwelling catheter secured to their leg so it did not cause additional injury.

• 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: 12391729
• MDR Text Key: 268928234
• Report Number: 1018233-2021-05303
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2024
• Device Model Number: FOL0101
• Device Catalogue Number: FOL0101
• Device Lot Number: JUFP8026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR