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 Inflammation (1932)

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, but no additional information was provided.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.Retain samples were reviewed from the reported lot and no issues were identified, all samples passed functional testing.The complaint could not be reproduced.Through additional communication with the importer, they reported that their sales team are well trained and experienced in using the grip-lok.The hospital where the complaint originated normally uses a different securement device, but were provided with an emergency shipment of grip-lok to tide them over until supply chain issues could be resolved.Vygon had reported that they had determined that some of the clinicians were not sufficiently trained by the hospital¿s education staff.The facility has since gone back to using a device with which they are familiar.Currently, there is no evidence that a manufacturing nonconformance contributed to the reported complaint.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

It was reported by (b)(6), tidi's distributor in (b)(4): patient with pain on the right arm with swelling for several days, the picc was out at several points (at least 5 points) because the bandage does not hold enough on the skin.

• 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 drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15801085
• MDR Text Key: 307315821
• Report Number: 2182318-2022-00133
• 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: 10/21/2022

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: 53001389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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