MAUDE Adverse Event Report: TIDI PRODUCTS LLC GRIP-LOK PICC/CVC SECUREMENT DEVICE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number 3601CVC

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Event Description

It was reported by vygon, tidi's medical device distributor in (b)(4), that: "the device did not support the dialysis cvc fixation element but allowed it to slide and then move until the dialysis cvc almost completely came out during the dialysis procedure; this event led to the suspension of the dialysis procedure for the time needed to insert a new dialysis cvc.".

Manufacturer Narrative

Product was not returned for evaluation.Therefore, this report is based on the information provided by the customer.There was no patient or caregiver injury reported as a result of this event.Historical complaint data was reviewed and found twelve complaints for securement devices for adhesive failure in the last 2 years, nine of which were reported by vygon customers in europe.The device history record for this lot was reviewed and found no nonconformance's or anomalies noted that could have contributed to this complaint.All reviewed samples passed inspection, including functional testing via hanging weight test.On-hand inventory of units from different lots was reviewed and found not to have the same issue.Additionally, sample retains were tested and no failures or malfunctions were identified.The units passed all testing and the complaint could not be reproduced.Currently, the most likely root cause of failures is due to new users and device training issues.Per the importer, training is planned to take place at the user facility.A capa was opened to address an observed increase in these types of complaints and had identified a secondary root cause related to the product design with material selection in conjuncture with lack of robust process validation.At this time, there is not enough evidence to confirm the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.As a result of an observed recent increase in reportable complaints for securement devices, an internal investigation has been launched (capa (b)(4).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).

• Brand Name: GRIP-LOK PICC/CVC SECUREMENT DEVICE
• 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: 14403679
• MDR Text Key: 291953728
• Report Number: 2182318-2022-00041
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2022

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: 3601CVC
• Device Catalogue Number: 3601CVC
• Device Lot Number: 50884052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1