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

Catalog Number FOL0102DT

Device Problems Disconnection (1171); Failure to Form Staple (2579)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

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 last stat lock would not stay clipped down.Per additional information via email from ibc on 21 sep 2020, no visible damage was observed by the patient, the patient believes the issue was due to a moulding error as they could not close the clip on two stat locks on their 1st attempt as they would spring back open however the rest of the batch was fine.

Event Description

It was reported that the last stat lock would not stay clipped down.Per additional information via email from ibc on 21sep2020, no visible damage was observed by the patient, the patient believes the issue was due to a moulding error as they could not close the clip on two stat locks on their 1st attempt as they would spring back open however the rest of the batch was fine.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be ¿clamp door opens unintentionally /incomplete engagement¿ with a potential root cause of ¿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: "statlock® foley stabilization device read carefully before use.Safety and efficacy considerations: the statlock® device is for single use only.Do not alter the statlock® device or components.Procedure must be performed by trained personnel with knowledge of anatomical landmarks, safe technique and potential complications.Not made with natural rubber latex contents: package includes statlock® stabilization system and skin preparation pad.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, unattended access device, diaphoretic or non-adherent skin.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.".

• 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 GA 30014
• MDR Report Key: 10620411
• MDR Text Key: 210422128
• Report Number: 1018233-2020-06310
• Device Sequence Number: 1
• Product Code: EYJ
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: FOL0102DT
• Device Lot Number: JUEQ2504
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1