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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

2/28/2022-(b)(4).According to the customer, the fixation is unreliable, high risk of "dropping" central track.Loss of adhesion may result in the accidental removal of the medical lines.These events may interrupt patient treatment and may contribute to patient injury.Therefore, this is reportable.

Manufacturer Narrative

Product from the same lot as the complaint unit was by the customer returned and evaluated.There was no patient or caregiver injury reported as a result of this event.(b)(4).Returned sample from the complaint lot was reviewed and found not to have the same issue.The unit passed all testing and the complaint could not be reproduced.The device history record for the complaint lot was reviewed and there were no nonconformances or anomalies noted that could have contributed to the reported failure identified.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.(b)(4).

• Brand Name: VYGON PICC/CVC SECUREMENT DEVICE - 3 IN 1
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise dr; WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 13871783
• MDR Text Key: 297682271
• Report Number: 2182318-2022-00004
• 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: 02/22/2022

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: 45983171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1