MAUDE Adverse Event Report: TIDI PRODUCTS LLC GRIP-LOK MEDIUM 10/PK STERILE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	3300M-10PK
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: because the complaint originated as an amazon review, information is very limited.Amazon will not provide their customer's contact information.There is no lot information available and the specifics of use of the device (what type or size of tube/device was being secured, was the product applied per the ifu etc.), are unknown.Without additional information, the complaint cannot be confirmed, nor can root cause be positively determined.Based on historical complaint data, possible root cause is related to new users and device training.As this device is likely being used by end users in a home setting, they may not be following the instructions for use and proper application protocol.An existing capa is open to mitigate these types of complaints and the overall complaint rate for this failure mode/product family is very low (0.004% over the last 2 years).Therefore, no further corrective or preventative actions are necessary.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 (b)(4).
Event or Problem Description
Amazon review: this expensive catheter stabilization device comes loose after a few days.It is very difficult to remove the catheter from the device.

• Brand Name: GRIP-LOK MEDIUM 10/PK 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: 21020188
• Report Number: 2182318-2024-00180
• Device Sequence Number: 3969240
• Product Code: KMK
• UDI-Device Identifier: 00618125134717
• UDI-Public: 00618125134717
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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
• Device Model Number: 3300M-10PK
• Device Catalogue Number: 3300M-10PK
• 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: 12/11/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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