MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK DEVICE

Model Number FOL0100

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/11/2023

Event Type  Injury  

Event Description

It was reported that patient were using another type of catheter that has been discontinued and currently tried foley statlock from two lots jugy8646, jugv1855.Once customer started using these statlock they experienced irritation and blisters along her legs, feet and some of the blisters bled and had pus.They had been treating them at home with hydrogen peroxide and witch-hazel, normally they had allergic reactions to adhesives and wants to know if there were any adhesives in this type of catheter.They had boxes of package date of 2020 and wants to know how they are packaged in 2020 but don't expire until 2025, wants to make sure they are still good to use.Per follow up via phone on (b)(6) 2023, it was reported that patient had stopped use of catheters and did not seek medical intervention.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 patient were using another type of catheter that has been discontinued and currently tried foley statlock from two lots jugy8646, jugv1855.Once customer started using these statlock they experienced irritation and blisters along her legs, feet and some of the blisters bled and had pus.They had been treating them at home with hydrogen peroxide and witch-hazel, normally they had allergic reactions to adhesives and wants to know if there were any adhesives in this type of catheter.They had boxes of package date of 2020 and wants to know how they are packaged in 2020 but don't expire until 2025, wants to make sure they are still good to use.Per follow up via phone on 01may2023, it was reported that patient had stopped use of catheters and did not seek medical intervention.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as the reported event was found to be not reportable.H11: section a through f - the information provided by bd represents all 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.H3 other text: the device was not returned.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 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 Key: 16862908
• MDR Text Key: 314492981
• Report Number: 1018233-2023-03108
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FOL0100
• Device Catalogue Number: FOL0102
• Device Lot Number: JUGY8646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention