SL FOLEY SWIVEL 25BX FOL0101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-01-24 for SL FOLEY SWIVEL 25BX FOL0101 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[178198242] The reported event was confirmed. Visual inspection noted one used foley statlock was received. An in-house foley catheter was placed in the clamp and the clamp was able to close down around the catheter properly. The catheter was pulled down with force to ensure that the clamp door remained closed, and it was found that the swivel base was disconnecting from the pad. 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: "warnings and precautions: 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. Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock? Device. Minimize catheter manipulation during application and removal of the statlock? Device. Daily maintenance: the statlock? Device should be assessed daily and changed when clinically indicated, at least every seven days. 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. If showering/bathing, cover with plastic wrap or waterproof dressing. Conduct skin assessment prior to application and repeat daily per facility protocol. Use clinical judgment on the removal of the statlock? Stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity. "
Patient Sequence No: 1, Text Type: N, H10


[178198243] It was reported that the swivel base was disconnecting from the pad.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-00506
MDR Report Key9629215
Report SourceCONSUMER,OTHER
Date Received2020-01-24
Date of Report2020-01-24
Date Mfgr Received2020-01-02
Device Manufacturer Date2019-07-14
Date Added to Maude2020-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSL FOLEY SWIVEL 25BX
Generic NameFOLEY CATHETERS
Product CodeEYJ
Date Received2020-01-24
Returned To Mfg2019-12-16
Catalog NumberFOL0101
Lot NumberJUDUF088
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-24

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