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  Injury  

Event Description

It was reported on 9/28/2023 by vygon, tidi's securement distributor in europe: on the patient's return from the placement of a picc-line, the puncture site is very hemorrhagic and the dressing is saturated within a few minutes (between 15 and 30 minutes).The dressing is re-dressed as soon as the patient returns, with coalgan and compresses to facilitate coagulation and stop bleeding.Coalgan is applied to the puncture site, and the compress is placed on top.The grip-lok is placed on dry, disinfected skin at a distance from the puncture site.The catheter hub is firmly nserted into the dedicated cut-out space.Within 15 minutes, the dressing is again saturated with blood.When the dressing was re-dressed for the second time, the catheter was pushed by the abundantly flowing blood and extended 15cm despite the grip lok attachment device.

Manufacturer Narrative

H3: product samples are not available for evaluation.Therefore, this report is based solely on customer-provided information.The customer was contacted for more information regarding the complaint.There was no lot information provided, so neither the device history record nor retain samples for the complaint lot could be reviewed.Through additional communication with the importer, they reported that the customer has received formal training on using the device.It was reported that the securement device was almost saturated with blood at the time of the picc-line extension, but that the device remained in place and stuck to the skin.Based on the description of the event and the fact that the device remained in place, the failure may have been due to saturation of blood on the adhesive between the bandage and line/foam cutout portion of the device, allowing the line to slip.The product ifu contains the note: ¿replace securement device if soiled or saturated in fluid or if device shows signs of wear or damage.¿ additionally, the event description states that the device was placed ¿at a distance from the puncture site.¿ in order to be effective, the device should be placed near the insertion site.Currently, it is believed that these factors contributed to the picc-line becoming extended.At this time, 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).

• 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: 17997801
• MDR Text Key: 326418514
• Report Number: 2182318-2023-00100
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5804.09
• Device Catalogue Number: 5804.09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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