MAUDE Adverse Event Report: VYGON GMBH NUTILINE; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1252.230

Device Problems Break (1069); Material Fragmentation (1261); Material Puncture/Hole (1504); Device Slipped (1584); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Affected device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are still pending and will be reported to fda within thirty days of its conclusion via follow-up mdr.

Event Description

On (b)(6) 2020 a nutriline twinflo was placed in a (b)(6) patient.Unfortunately, the catheter was not in the vein as suspected, but rolled up in the tissue of the elbow.When the stylet was pulled, it tore, but could be removed completely.When the catheter was flushed, a leaky spot appeared just behind the puncture site.Then the doctor tried to pull the catheter, but it snapped and got stuck in the child for at least 27 cm.The catheter had to be removed surgically.Catheter was in the tissue.No further consequences were reported.

Manufacturer Narrative

We received only the catheter tubing as a reference sample, which snapped proximal the 30 cm marking.The tube was pushed together between the 15 cm and 20 cm mark like an accordion.Clear darker occlusions (blood?) were visible in the catheter.A microscopic examination showed that the catheter tube had been cut off during stylet removal when the catheter tube rolled up.When this occurs, it is possible for the stylet to cut the catheter's wall.The product's ifu regarding stylet problems states: "if difficulty is experienced stop, let vein rest for a minute and try removal again very slowly.Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal.If resistance still remains, withdraw catheter and stylet simultaneously." and further "the catheter lumens are not suitable for blood aspiration".There were no abnormalities in batch documentation review.A leak and flow test is performed on each catheter prior to product packaging.A tensile strength test is performed randomly as an in-process inspection.In addition, 100% visual inspections are performed twice and a seal seam inspection.An incoming goods inspection is carried out for all components.This is the first complaint for ch.-no.190717go and the first concerning a catheter tube sheared off when removing the stylet for art.No.1252.230.No further corrective action initiated by quality management as there are no indications for a manufacturing fault.

Event Description

On (b)(6) 2020 a nutriline twinflo was placed in a 2 years old patient.Unfortunately, the catheter was not in the vein as suspected, but rolled up in the tissue of the elbow.When the stylet was pulled, it tore, but could be removed completely.When the catheter was flushed, a leaky spot appeared just behind the puncture site.Then the doctor tried to pull the catheter, but it snapped and got stuck in the child for at least 27 cm.The catheter had to be removed surgically.Catheter was in the tissue.No further consequences were reported.

• Brand Name: NUTILINE
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• MDR Report Key: 10245288
• MDR Text Key: 197951716
• Report Number: 2245270-2020-00060
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K052475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1252.230
• Device Lot Number: 190717GO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR