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

Catalog Number FOL0101

Device Problems Disconnection (1171); Product Quality Problem (1506); Defective Component (2292); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 statlocks would not stay closed.The patient advised that the locks began to unlock after approximately 24hrs of use.

Event Description

It was reported that the statlocks would not stay closed.The patient advised that the locks began to unlock after approximately 24hrs of use.

Manufacturer Narrative

The reported event was unconfirmed.Visual inspection noted 19 unopened foley statlocks were received.Visual evaluation noted all 19 foley statlocks were able to open and close as intended.An in house catheter was inserted into each device, and the clamps easily closed around all 19.Each time the catheter was pulled on with an excessive amount of force, and the clamp remained engaged.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: ¿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.".

• Brand Name: SL FOLEY SWIVEL 25BX
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8863924
• MDR Text Key: 153670522
• Report Number: 1018233-2019-04479
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: FOL0101
• Device Lot Number: JUDPF279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1