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

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

Patient Problem Discomfort (2330)

Event Date 08/26/2021

Event Type  malfunction  

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 statlock device was not staying closed.Three of the four locking devices had opened on their own.The device clicked to the closed position, appeared to be secured and then when the customer checked, the lock had opened.The patient was primarily sedentary.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.But customer was unable to attribute which lot was used that was defective.Per additional information via email on 26aug2021, 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 pulls on.Customer take secondary measures to keep the indwelling catheter secured to their leg so it did not cause additional injury.No medical intervention was reported.

Manufacturer Narrative

The reported event is confirmed - cause unknown.Visual inspection noted one opened statlock was received.Confirmed that clamp popped open easily when light/normal pressure was applied to in house catheter.This does not meet specifications stating the device will be a rejection if it is damaged in a way which affects functionality.Although an exact root cause could not be determined, a potential root cause is material handling failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.The device was 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: "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." corrections: d,h 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 actual/suspected device was inspected.

Event Description

It was reported that the statlock device was not staying closed.Three of the four locking devices had opened on their own.The device clicked to the closed position, appeared to be secured and then when the customer checked, the lock had opened.The patient was primarily sedentary.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.But customer was unable to attribute which lot was used that was defective.Per additional information via email on (b)(6) 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 pulls on.Customer take secondary measures to keep the indwelling catheter secured to their leg so it did not cause additional injury.No medical intervention was reported.

• Brand Name: UNKNOWN STATLOCK SL FOLEY
• Type of Device: UNKNOWN STATLOCK SL FOLEY
• 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: 12487930
• MDR Text Key: 271896421
• Report Number: 1018233-2021-05739
• Device Sequence Number: 1
• Product Code: EYJ
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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