MAUDE Adverse Event Report: VYGONGMBH EPICUTANEO CAVA; LONG-TERM INRAVASCULAR CATHETER

Model Number 2184.00

Device Problems Material Rupture (1546); Migration (4003)

Patient Problems Extravasation (1842); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion.

Event Description

Rupture of the neonatal epicutaneous catheter, with approximately 20 cm of the catheter remaining in the vascular interior.

Manufacturer Narrative

This complaint is not confirmed.(classification according to sop 002).We received one catheter as a sample: the extension line with assembled easy-lock adapter and catheter tube shortened at approx.22.8 cm.Microscopic examination of the tube fragment showed a smooth and slightly wavy surface.Cross section of the lumen slightly oval with a small protrusion.This indicates that the catheter tube has been mechanically damaged/cut.The distal end of the catheter tube is missing.The proximal end part of the catheter tube with the bold black marking and metal tube is not assembled correctly.The black marking is completely visible outside the easy lock with additional white catheter tube having checked the batch history records, no deviations were found.The batches complied to its 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.There is one further complaint for the batch 230622gg, four further complaints for the batch 011122gg, but no further complaint for batch 030622gg.There were eight further complaints regarding a snapped/cut catheter on code 2184.00 within the last three years.No further corrective action initiated by quality management as there are no hints of a manufacturing fault.

Event Description

Rupture of the neonatal epicutaneous catheter, with approximately 20 cm of the catheter remaining in the vascular interior.

• Brand Name: EPICUTANEO CAVA
• Type of Device: LONG-TERM INRAVASCULAR CATHETER
• Manufacturer (Section D): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 16529894
• MDR Text Key: 311211137
• Report Number: 2245270-2023-00017
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K897168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2184.00
• Device Lot Number: 230622GG, 011122GG, 030622GG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2023
• 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 Outcome(s): Required Intervention