MAUDE Adverse Event Report: VYGON USA NUTRILINE; INTRAVASCULAR CATHETER

Model Number	1252.35G
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Picc nurse called to bedside of patient to assess wet dressing.Picc rn assessed and noted that picc dressing was wet and biopatch was soaked.Picc rn lifted dressing and noted the picc leaking iv fluids at the hub.Picc was removed and md notified.Bedside nurse reported that dressing had been changed 2 hours prior to the line lieaking.
Additional Manufacturer Narrative
Due to the missing sample, the root cause of this issue could not be confirmed.Unfortunately, we did not receive the defective sample from the customer.But we received a similar complaint from the same customer for the same batch.There was a microhole at the junction of the catheter with the fixation wing.The catheter tube was partly torn from the fixation wing.Microscopic examination of the fracture plane showed a rough and uneven surface, which is a typical sign of a tensile fracture due to a high tensile load.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 8138680 and 8150602 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 visual tests after packaging are conducted with no exceptions found.We received eight complaints for batch no.8138680 and six complaints for batch no.8150602.Eleven similar complaints regarding a leaking catheter tube at the junction of the catheter and the fixation wing on code 4g07125235 were received within the last three years, but none of them were related to a manufacturing defect.
Event or Problem Description
Picc nurse was called to bedside of patient to assess wet dressing.Picc rn assessed and noted that picc dressing was wet and biopatch was soaked.Picc rn lifted dressing and noted the picc leaking iv fluids at the hub.Picc was removed and md notified.Bedside nurse reported that dressing had been changed 2 hours prior to the line leaking.
Event or Problem Description
Picc nurse was called to bedside of patient to assess wet dressing.Picc rn assessed and noted that picc dressing was wet and biopatch was soaked.Picc rn lifted dressing and noted the picc leaking iv fluids at the hub.Picc was removed and md notified.Bedside nurse reported that dressing had been changed 2 hours prior to the line leaking.

• Brand Name: NUTRILINE
• Common Device Name: 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: wanda dumont ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 17423681
• Report Number: 2245270-2023-00046
• Device Sequence Number: 5955529
• Product Code: LJS
• UDI-Device Identifier: 00849884000870
• UDI-Public: 00849884000870
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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: 10/31/2024
• Device Model Number: 1252.35G
• Device Lot Number: 21I004D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 08/15/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 9 MO
• Patient Sex: Male