MAUDE Adverse Event Report: TIDI PRODUCTS LLC GRIP-LOK UNIVERSAL SECUREMENT DEVICE, LARGE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	3400L
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: it is currently unknown if product is available to be returned for evaluation.Therefore, this report is based solely on the information provided by the customer.Complaint was reported to the manufacturer by the end user directly via an online feedback portal.We have attempted to contact the customer at the email address provided but have so far received no response.There is no lot information available for the affected product, so the device history record could not be pulled for review.At this time, there is no evidence that a manufacturing error contributed to the reported failure.Based on historical complaint data and information currently available, likely root cause is due to new users and device training issues.There have been a total of 3 complaints for this failure mode and product family in the last 2 years.Based on sales data, this issue has a complaint rate of (b)(4) during that 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 (b)(4).
Event or Problem Description
Customer reported via hubspot: i ordered a box of grip loks sz large online they are not sticking they fall off overnight.I really needed these to keep my tube in place while i wait on surgery.Can you help me these are defective.

• Brand Name: GRIP-LOK UNIVERSAL SECUREMENT DEVICE, LARGE
• 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: 19082841
• Report Number: 2182318-2024-00044
• Device Sequence Number: 12824139
• Product Code: KMK
• UDI-Device Identifier: 00618125134755
• UDI-Public: 00618125134755
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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: 3400L
• Device Catalogue Number: 3400L
• 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: 03/11/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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