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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 Problems Disconnection (1171); Difficult to Open or Close (2921)
Patient Problem Discomfort (2330)
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 statlock did not stay closed around the 16fr.Catheter after a few days of use.The complainant reported that as a result of the statlock popping open, the foley catheter was left dangling and not supported which reportedly caused some discomfort.
 
Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation noted one used foley statlock received without the packaging or catheter.No obvious defects were noted.The device was able to be opened and closed as intended.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." h11:section a through f - the information provided by bd 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 bd.H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that the statlock did not stay closed around the 16fr.Catheter after a few days of use.The complainant reported that as a result of the statlock popping open, the foley catheter was left dangling and not supported which reportedly caused some discomfort.
 
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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 Key8433128
MDR Text Key139307763
Report Number1018233-2019-01422
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 05/16/2019
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 Catalogue NumberFOL0102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2019
Initial Date Manufacturer Received 02/27/2019
Initial Date FDA Received03/19/2019
Supplement Dates Manufacturer Received04/26/2019
Supplement Dates FDA Received05/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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