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

Model Number	1252.030G
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.
Event or Problem Description
Leaking where the line begins.
Event or Problem Description
Leaking where the line begins.
Additional Manufacturer Narrative
The malfunctioning device has not yet been returned to vygon for testing as part of the complaint investigation.
Event or Problem Description
Leaking where the line begins.
Additional Manufacturer Narrative
The complaint was forwarded to our parent company in germany for their evaluation.The investigation summary is as follows: we received one catheter as a sample.A needle-free connector was connected to the luer lock hub.During the microscopic examination, we found a hole at the junction of the catheter with the fixation wing.The catheter tube was partly torn out of the fixation wing.The fracture plane showed a rough and uneven surface, which is a typical sign of a tensile fracture due to a high tensile load.The complaint cannot be confirmed to be caused by manufacturing.There are various possible causes that can lead to catheter leakage/tensile fracture: · dressing change - in some instances, the catheter can become adhered to the dressing and additional pulling is used to free it, placing stress on the line which could result in a tensile fracture.· routine care - when lifting the baby to change bedding.· mechanical damage by a sharp instrument (for example scissors, toothed forceps, or scalpel) during dressing change.· movement - the baby themselves catching the line, normally with a foot, during movement.· use of alcohol-based disinfectant.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." and "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 8137379 and 8178394 was performed, and no deviations were found.The batches complied with its specifications and were released.Each catheter is flow and leak-tested during production.The tensile force and dimensions of catheter components are randomly checked.Incoming goods inspections and two 100 % visual tests after packaging are conducted with no exceptions found.There are ten further complaints for batch 8137379, nine further complaints for batch 8178394, and six further complaints regarding a catheter tube torn out of the fixation wing on code 4g07125203 within the last three years, but none of them were related to a manufacturing defect.Corrective action: no further corrective action is initiated by quality management due to this complaint, as there are no indications of a manufacturing fault.Any manufacturing problems that would lead to a leak would be detected by the user when initially flushing the catheter.When using an alcohol-based disinfectant, we recommend following the catheter handling instructions according to the product's ifu.

• Brand Name: NUTRILINE
• Common Device Name: 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
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 17423611
• Report Number: 2245270-2023-00052
• Device Sequence Number: 7571997
• Product Code: LJS
• UDI-Device Identifier: 00849884000825
• UDI-Public: 00849884000825
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 1252.030G
• Device Lot Number: 22I007D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 07/12/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/18/2023; 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 4 KG