MAUDE Adverse Event Report: TIDI PRODUCTS LLC VYGON PICC/CVC SECUREMENT DEVICE - 3 IN 1; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number 5804.09

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Product samples are not available for evaluation.Therefore, this report is based solely on customer-provided information.The customer has been contacted for more information regarding the complaint.A response is pending.The device history record for the complaint lot was reviewed and identified no nonconformances or anomalies that could have contributed to the reported complaint.All reviewed samples passed inspection before release for distribution.Historical complaint data review identified 17 similar complaints for adhesive failure for securement devices in the last 2 years, mostly from vygon customers in europe.This failure mode has a complaint rate of (b)(4) year-to-date.Currently, there is no evidence that a manufacturing nonconformance contributed to the reported complaint.A capa has been opened to address reportable complaints for securement devices.No further corrective or preventive action is required at this time.We will continue to monitor for these types of complaints.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 Description

Vygon, a medical device distributor in europe, reported the following: according to the customer, a patient moved during the night and the device to hold the picc line in place did not prevent this.The base of the picc line comes off the bandage even though the bandage sticks well to the skin.We have had this problem twice already this month since the device was changed.No pictures.

• Brand Name: VYGON PICC/CVC SECUREMENT DEVICE - 3 IN 1
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15201866
• MDR Text Key: 304974460
• Report Number: 2182318-2022-00097
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/11/2022

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: 5804.09
• Device Catalogue Number: 5804.09
• Device Lot Number: 49221247
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1