MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX & SILICONE SL FOLEY SWIVEL SILICONE TRICOT, 5 PACK; STATLOCK

Catalog Number FOL0102DT

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure could be inappropriate snap fit.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.Cleanse and degrease the outlined stabilization site (fig.1) with alcohol or as recommended in your local policy.This is important to remove any lotions or oils from the skin so the anchor pad will hold well.Allow to dry completely.2.Apply the skin protectant provided in the direction of hair growth, to an area larger than the same stabilization site (anterior [front of thigh] or abdomen).Allow to dry completely (10¿15 seconds).Note: it is not usually necessary to trim the hair prior to placement.The skin prep should be used in the direction of the hair growth which will lay flat as it dries and the anchor pad usually holds in place very well.If it is necessary to trim the hair, do so as recommended by your local policy.Be careful to always trim and avoid shaving as this causes micro-abrasions which can increase infection risk.Press peel & place 3.Align the anchor pad over stabilization site (fig.2) so the directional arrow on retainer points toward the catheter tip.Press foley catheter into retainer.The large side (urine channel) goes in the large space and the small side (balloon channel) goes in the small space.This helps to ensure the right fit so the retainer will close properly.4.Close the lid properly by pressing at the edge, not the center, being careful to avoid pinching the catheter (fig.3).5.Position on the anterior thigh or abdomen, leaving no more than 2.5 cm of catheter slack between insertion site and the statlock® device retainer.6.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 (fig.4).Disengage 1.Open the retainer by gently pressing the button with the thumb then lift to open (fig.6).2.Remove the foley catheter (fig.7).Dissolve 3.First lift the edge of the anchor pad using 3¿4 alcohol swabs by stacking them together and working under the edge of the pad (fig.8).Then continue to stroke the undersurface of pad with the alcohol to dissolve anchor pad adhesive away from the skin.".

Event Description

It was reported that the statlocks in the patient's new box kept unclipping and the patient was unable to keep them closed over the catheter.

• Brand Name: LATEX & SILICONE SL FOLEY SWIVEL SILICONE TRICOT, 5 PACK
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8926360
• MDR Text Key: 194800564
• Report Number: 1018233-2019-05067
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076138
• UDI-Public: (01)00801741076138
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: FOL0102DT
• Device Lot Number: JUAVF407
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2016
• 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