MAUDE Adverse Event Report: VYGON USA NUTRILINE; LONG-TERM INTRAVASCULAR CATHETER

Model Number 252.230G

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/29/2023

Event Type  malfunction  

Manufacturer Narrative

The failed 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 communicated to fda within 30 days of its conclusion.

Event Description

Picc was inserted (b)(6) 2022.Picc was inserted to the 15cm mark.Leaking noted at 17-18cm mark.Picc had a biopatch in place.Site had been cleaned with chloraprep with previous dressing changes.

Event Description

Picc was inserted on (b)(6) 2022.Picc was inserted to the 15cm mark.Leaking noted at 17-18cm mark.Picc had a biopatch in place.Site had been cleaned with chloraprep with previous dressing changes.

Manufacturer Narrative

The sample is still in decontamination process and has not been returned for evaluation.The results of this investigation is still pending.

Event Description

Picc was inserted (b)(6) 2022.Picc was inserted to the 15cm mark.Leaking noted at 17-18cm mark.Picc had a biopatch in place.Site had been cleaned with chloraprep with previous dressing changes.

Manufacturer Narrative

We received a 30 cm nutriline twinflo catheter as a sample.The catheter tube has adhesive residues.At both lumen a non-vygon needle-free connection system was connected.Examination of the returned sample showed the green lumen was flushable without any problems, but the orange lumen demonstrated severe occlusions in the catheter tube.When flushing the catheter over the orange lumen, it was leaking near 17-18 cm from the distal, and the distal was completely blocked.During microscopic examination, a micro longitudinal tear (cut or pressure burst) became visible in this area.Based on the product incident report (pir), the customer used alcohol based chloraprep as a disinfectant.There is a statement in our product's ifu: "be aware that organic solvents such as alcohol or acetone may interact with catheter material and weaken it.Avoid any contact of the catheter tubing to alcohol containing disinfectants.This may irreversibly damage the catheter.A review of the batch history records for batch no.8137379 and 8178394 was performed, and no deviations were found.The batches conform to specifications and were released.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out with no exceptions found.There are three further complaints for the batch 8168372 but no further complaint for batch 8172398.There were seven further complaints regarding a leaking catheter on code 4g07125223 within the last three years.Corrective action: as the catheter worked well for 60 days (catheter is indicated for use up to 29 days) before the leakage occurred, we do not believe this defect is manufacturing related.Any manufacturing problems that would lead to a leak would be detected by the user when flushing the catheter.Therefore, no further corrective action will be initiated at this time.

• Brand Name: NUTRILINE
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820 3816
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 16435050
• MDR Text Key: 310350498
• Report Number: 2245270-2023-00013
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 252.230G
• Device Lot Number: 22E006D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 6 MO
• Patient Sex: Male
• Patient Weight: 6 KG