MAUDE Adverse Event Report: TIDI PRODUCTS LLC GRIP-LOK LG FOLEY STERILE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	3400LFC
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device was not returned for evaluation.Therefore, this event is reported based solely on the information provided by the customer.The instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Review of design documents for this product indicate that the device must be compatible on skin for up to 7 days of wear time.Lot information for the complaint product was not provided, so manufacturing documentation could not be reviewed.Historical complaint data review identified other similar complaints for this product family in the last 2 years for failure to hold/secure the tube or line, though the complaint rate is low based on sales data over the same period of time.A capa has been initiated to address these types of complaints.The likely root cause was identified to be related to new users and device training issues.Currently, based on the information available, the complaint cannot be confirmed nor can root cause be determined.Capa-2022-0002 has been initiated to address reportable complaints for securment devices.Therefore, no further corrective or preventive actions are required at this time.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file: 2024-00564 h3 other text : device not returned.
Event or Problem Description
It was reported by the customer: "i'm 71 years old, and i clean and dry my leg correctly, so it's nice and dry.I have no hair on that part of my body because, lucky for me, i'm not a hairy person.Just to clarify it for you, the grip-lok remains on my leg beautifully, but the white layer on top that secures the catheter tube comes off within a few days.".

• Brand Name: GRIP-LOK LG FOLEY STERILE
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 19491256
• Report Number: 2182318-2024-00073
• Device Sequence Number: 7090007
• Product Code: KMK
• UDI-Device Identifier: 00618125134779
• UDI-Public: 00618125134779
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 3400LFC
• Device Catalogue Number: 3400LFC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown