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

Catalog Number FOL0100

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed.A visual evaluation noted one used foley statlock was received.The retainer was observed disconnected from the pad.Although the reported event was confirmed, a definitive root cause can not be determined.A potential root cause could be "glue selection incompatible with clamp base".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: "contents: package includes the statlock® device 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: 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.Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock® device.Minimize catheter manipulation during application and removal of the statlock® device.Daily maintenance: the statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.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.If showering/bathing, cover with plastic wrap or waterproof dressing.Conduct skin assessment prior to application and repeat daily per facility protocol.Use clinical judgment on the removal of the statlock® stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity.".

Event Description

It was reported that the clip broke off of the statlock deeming it unusable.

• Brand Name: SL FOLEY SWIVEL SILICONE 25BX
• Type of Device: STALOCK
• 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: 8960840
• MDR Text Key: 199857855
• Report Number: 1018233-2019-05337
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• 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: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: FOL0100
• Device Lot Number: JUCYF274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• 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