MAUDE Adverse Event Report: TIDI PRODUCTS LLC VYGON PICC/CVC SECUREMENT DEVICE - MAX FLO; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number 5804.10

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 10/29/2022

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.There lot number for the complaint device is unknown, therefore the device history record could not be reviewed.There were several images of the complaint device provided by the end user.The product instructions for use contain the following warning: ¿note: replace securement device if soiled or saturated in fluid or if device shows signs of wear or damage.¿ images provided were reviewed and appear to show saturation of the grip-lok device with fluid as indicated by discoloration of one of the wings.There is also evidence from the images that the tegraderm applied over the grip-lok had failed before the grip-lok did.The root cause of the failure is believed to be a failure to identify and replace a unit that had been saturated in fluid.This information was provided to the importer to be forwarded to the end user, along with a current copy of the device instructions for use.Currently, there is no evidence that a manufacturing nonconformance contributed to the reported complaint.Therefore, no corrective or preventive action is required.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 2022-01330.

Event Description

Complaint: (b)(4) on the (b)(6), the patient was found in the morning (usually calm), with a maladjustment of her piccline and her dressing.The piccline is only held in place by a scratch (dressing done again on (b)(6), the patient does not usually pull on the dressing.Other information: no washing, just dressing repair following a 4-step protocol:, rinsing, drying, chlorinex and waiting for drying before hibiscrub, rinsing, drying, chlorinex and waiting for drying before gluing the griplok and tegaderm to close it well.R that did not hold it is the sticky part on the wings of the catheter that did not hold anymore, so the catheter was able to come out of the housing provided.

• Brand Name: VYGON PICC/CVC SECUREMENT DEVICE - MAX FLO
• 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: 16184335
• MDR Text Key: 307505381
• Report Number: 2182318-2022-00152
• 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: 12/19/2022

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 Operator: Health Professional
• Device Model Number: 5804.10
• Device Catalogue Number: 5804.10
• Device Lot Number: 53112982
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 38 KG