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  

Manufacturer Narrative

H3: product samples are not available for evaluation.Therefore, this report is based solely on customer-provided information.Through additional communication with the importer, they reported that the user facility has recently switched to using this device from another brand.It was reported that the securement devices were saturated with discharge from the patient that stains the device prior to adhesive failure.The product ifu contains the note: ¿replace securement device if soiled or saturated in fluid or if device shows signs of wear or damage.¿ in order to be effective, the device should be kept clean and dry.Historical complaint data review found that similar complaints have been reported from new users with similar circumstances.An internal investigation identified root cause as new user/training issues.The distributor has reported that a trade commissioner visited the hospital after the complaint was received and provided in-service training and materials.There have been no new complaints reported by this care facility.At this time, the likely root cause is related to new users, lack of training, and failure to follow instructions for use.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 vygon, tidi's european grip-lok distributor, the final user informed vygon of a defect occurred several times with this sku of grip-lok: on many occasions, the caregivers notice a discharge which stains the dressing and prevents it from being maintained properly, despite use of tegaderm dressing.Change of piccline device and dressing.This device was used with a picc from bd, reference vppc spce.

• 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: 18534068
• MDR Text Key: 333516232
• Report Number: 2182318-2023-00130
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 555212486
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1