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

Model Number FOL0102

Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported that the statlock seemed to be bent and was very difficult to open.The patient was admitted into the intensive therapy unit for accident and emergency, but the patient complained of pain in their penis due to a catheter.Upon inspection, the customer realized that the lubrisil catheter had not been placed correctly into the statlock ( it was placed too high up the catheter and not at the site of the port to inflate the balloon).When the customer attempted to open the statlock to reposition the catheter, after several attempts it was difficult to operate the locking mechanism correctly.So the customer decided to remove the statlock with apeel medical adhesive remover and to secure the catheter with a new statlock.Upon removal, the customer noted that the clip of the original statlock was bent and the user considered that might have caused difficulty in opening it.It was unknown what medical intervention was provided for the pain.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "handling error / process error".The device was not 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: "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 degrease 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 undersurface of pad with alcohol to dissolve adhesive pad away from skin.Do not pull or force pad to remove." corrections: f, h h11: section a through f - the information provided by bd represents all 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 statlock seemed to be bent and was very difficult to open.The patient was admitted into the intensive therapy unit for accident and emergency, but the patient complained of pain in their penis due to a catheter.Upon inspection, the customer realized that the lubrisil catheter had not been placed correctly into the statlock ( it was placed too high up the catheter and not at the site of the port to inflate the balloon).When the customer attempted to open the statlock to reposition the catheter, after several attempts it was difficult to operate the locking mechanism correctly.So the customer decided to remove the statlock with apeel medical adhesive remover and to secure the catheter with a new statlock.Upon removal, the customer noted that the clip of the original statlock was bent and the user considered that might have caused difficulty in opening it.It was unknown what medical intervention was provided for the pain.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17292340
• MDR Text Key: 318806793
• Report Number: 1018233-2023-05021
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male