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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK
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C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK Back to Search Results
Catalog Number FOL0102
Device Problem Disconnection (1171)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of 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 bard.
 
Event Description
It was reported that the plastic clamp was allegedly disconnected from the adhesive pad.Three units failed within a week for the same client.The client is an experienced user with no previous issues.One sample was returned for investigation.It was assumed that all 3 came from the same lot but the first 2 were discarded.
 
Manufacturer Narrative
The reported event was inconclusive due to the entire product not being returned.Received 1 used statlock clamp only with the original packaging.It was observed that neither the tricot pad nor the base returned for evaluation.Only the retainer came back and in a closed position.The retainer opened and closed as specified.Under microscopic inspection, the retainer exhibits damages on its inner circle circumference (connection with base).Due to the damages observed in the inner circumference of the retainer it seems that a pulling force was applied to disengage it from the base.This suggests the possibility of an unknown user-related factor.However, the cause remains unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "contents: package includes the statlock® device stabilization system and skin preparation pads.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, diaphoretic or nonadherent skin, or when the access device is not monitored daily.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.Application technique 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.The statlock® stabilization device should be monitored daily and replaced when clinically indicated, at least every 7 days.The catheter insertion site should be treated per local policy recommendations.The statlock® device is contraindicated on patients with known tape and adhesive allergies.Alcohol and acetone may weaken the adhesive bond between the statlock® device pad and the skin.Care should be taken when using these solutions while performing catheter site care.Please consult product inserts and labels for any indications, contraindications, hazards, warnings, cautions and directions for use.For additional information on the statlock® foley stabilization device, please call your local bard® representative." (b)(4).
 
Event Description
It was reported that the plastic clamp was allegedly disconnected from the adhesive pad.Three units failed within a week for the same client.The client is an experienced user with no previous issues.One sample was returned for investigation.It was assumed that all 3 came from the same lot but the first 2 were discarded.
 
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Brand Name
SL FOLEY SWIVEL SILICONE TRICOT 25BX
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7132118
MDR Text Key95540363
Report Number1018233-2017-06399
Device Sequence Number1
Product Code EYJ
UDI-Device Identifier00801741076114
UDI-Public(01)00801741076114
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2020
Device Catalogue NumberFOL0102
Device Lot NumberJUBSF110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Date Manufacturer Received02/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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