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

Model Number 3200S

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

5/19/23 mcarthur complaint #: mca0639 grip-lok not securing tubes.Have had 2 incidents of abdominal tubes falling out and 1 chest tube falling out.The tubes were not in for longer than 2 days.

Manufacturer Narrative

The actual complaint product was not available for evaluation.Retain samples from the reported lot were evaluated.Multiple retain samples were tested for adhesive functionality via hanging weight test.All reviewed samples passed the test and functioned per original release specifications.The reported complaint could not be duplicated.The device history record for this lot was reviewed and there were no issues noted that could have contributed to the reported issue.The reporter was contacted for more information regarding the event and the users and it was reported that they are new users who are using the grip-loks as a substitution due to supply chain issues.Previously used devices: statlock and flexitrak.Similar complaints have been reported from former stat-lok users due to the more aggressive adhesive used in that device.The customer has reported that the griplok either fell off the patient completely or the griplok did not move, but the design allowed the tube to slip out entirely from normal patient movement.The adhesive on the top flap did not stick to the tube.Sku 3200s is a small grip-lok intended for use with tubing sizes 4.5 - 14 fr.The customer was contacted for more information on how the device was being used, but no information was received.It is believed that the grip-lok selected was not the correct one for use as described in the incident report, and that a larger model should be used with the tube sizes typically associated with the uses described.The account manager was contacted to provide the customer with alternate skus from the tidi profile to better suit their needs.At this time, it appears that the root cause is related to new users and incorrect device selected for its application.The reporter is being provided with alternate products to better suit their needs.No further corrective or preventive actions are required currently.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).

• Brand Name: GRIP-LOK SMALL STERILE
• Type of Device: 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: 17140012
• MDR Text Key: 317342151
• Report Number: 2182318-2023-00053
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 00618125134656
• UDI-Public: 00618125134656
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3200S
• Device Catalogue Number: 3200S
• Device Lot Number: 54958082
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1