Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKOWN FOLEY STATLOCK
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKOWN FOLEY STATLOCK Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Patient Problem Skin Irritation (2076)
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 home care staff was unable to get the statlock to stick for the 7 day period.It would fall off frequently within 24 to 72 hours and skin breakdown was occurring.The client has a medicated cream that was applied to old areas of application and not under new areas.Due to the alleged skin irritation and breakdown, the staff were cleaning the skin with soap and water, not alcohol, to avoid further irritation.It was reported to be thought that it may have been the client's oils interfering with the adhesive, or perhaps soap residue left on the skin after cleaning.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warnings and precautions: 1.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.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.".
 
Event Description
It was reported that the home care staff was unable to get the statlock to stick for the 7 day period.It would fall off frequently within 24 to 72 hours and skin breakdown was occurring.The client has a medicated cream that was applied to old areas of application and not under new areas.Due to the alleged skin irritation and breakdown, the staff were cleaning the skin with soap and water, not alcohol, to avoid further irritation.It was reported to be thought that it may have been the client's oils interfering with the adhesive, or perhaps soap residue left on the skin after cleaning.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STATLOCK SL FOLEY, UNKNOWN CODE
Type of Device
UNKOWN FOLEY STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8310853
MDR Text Key135699245
Report Number1018233-2019-00651
Device Sequence Number1
Product Code EYJ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-