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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 25BX; STATLOCK DEVICE

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C.R. BARD INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE 25BX; STATLOCK DEVICE Back to Search Results
Model Number FOL0101
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2023
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 foley statlock was not working, and it was too small, so the tube was not fitting.The nurse was not able to make it work either they used three out of the box of ten.
 
Event Description
It was reported that the foley statlock was not working, and it was too small, so the tube was not fitting.The nurse was not able to make it work either they used three out of the box of ten.
 
Manufacturer Narrative
The reported event is unconfirmed- product met specifications.Visual inspection noted received 1 statlock stabilization device with no original packaging with no obvious detects.Placed in house foley catheter on statlock stabilization device and was able to close device properly with no difficulties.Therefore, the product met specifications.Although an exact root cause could not be determined, a potential root cause 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: "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 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.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." h11: section a through f - 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.
 
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Brand Name
SL FOLEY SWIVEL SILICONE 25BX
Type of Device
STATLOCK DEVICE
Manufacturer (Section D)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key16503874
MDR Text Key310908275
Report Number1018233-2023-01557
Device Sequence Number1
Product Code EYJ
UDI-Device Identifier00801741076091
UDI-Public(01)00801741076091
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/18/2023
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 Date10/28/2023
Device Model NumberFOL0101
Device Catalogue NumberFOL0101
Device Lot NumberJUEX0934
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2023
Initial Date FDA Received03/08/2023
Supplement Dates Manufacturer Received04/18/2023
Supplement Dates FDA Received04/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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