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

Model Number 1252.15

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Affected devices 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

Two nutriline broke in the operating room.One of them in a baby, and the other in the preparation.The invasion surgeons had to remove the product.The baby is alive.Only one incident is reportable as it was necessary to surgically removed the catheter.The other sample obviously snapped during catheter preparation.

Event Description

Two nutriline broke in the operating room.One of them in a baby, and the other in the preparation.The invasion surgeons had to remove the product.The baby is alive.Only one incident is reportable as it was necessary to surgically removed the catheter.The other sample obviously snapped during catheter preparation.

Manufacturer Narrative

The two catheters returned by the customer were examined.Upon flushing both catheters were leaking next to the fixation wing.Microscopic examination showed that both catheters have been partly torn out of the fixation wing.Typically, these complaints are related to tensile traction under influence of the use of alcohol-based disinfectants and/or faulty fixation.As each catheter is leak and flow tested before packaging, we can exclude a manufacturing defect.We do not understand why the customer claimed that one catheter fragmented and had to be removed surgically.They either returned the wrong samples or the complaint description was incorrect.The distributor was unable to solve this contradiction, as due to the pandemic, he did not find any physician at the reporting hospital who witnessed this incident.Each catheter is leak and flow tested during production.The tensile force of the catheter components is randomly checked.Visual tests are carried out for product/component presence, the presence in cavities and the integrity of the product seal.This is the first complaint received for batch no.051219gl and the first complaint received for a ruptured catheter on code 1252.15 within the last 3 years.Regarding catheter leakage at the fixation wing 2 similar complaints were registered within the last three years.

• 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: 10250455
• MDR Text Key: 198114037
• Report Number: 2245270-2020-00061
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K051690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1252.15
• Device Lot Number: 051219GL
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention