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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; STATLOCK

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C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL; STATLOCK Back to Search Results
Catalog Number FOL0101
Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the statlock fell off almost immediately after it was put on.No medical intervention was reported.
 
Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿adhesive /hydrocolloid contaminated/dirty¿.A potential root cause for this failure mode could be ¿material handling¿.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." the device was not returned.
 
Event Description
It was reported that the statlock fell off almost immediately after it was put on.No medical intervention was reported.
 
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Brand Name
SL FOLEY SWIVEL
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8630667
MDR Text Key145742337
Report Number1018233-2019-02659
Device Sequence Number1
Product Code EYJ
UDI-Device Identifier00801741076091
UDI-Public(01)00801741076091
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 06/20/2019
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 NumberFOL0101
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/30/2019
Initial Date FDA Received05/22/2019
Supplement Dates Manufacturer Received06/02/2019
Supplement Dates FDA Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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