MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP JR.; CATHETER, CONTINUOUS FLUSH

Model Number	VMP406
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A report is being submitted due to product evaluation findings.As received the pressure tubing was completely detached from the bond joint with sample site.Indication of bonding material was evident on tubing bond surface area.Tubing od, 0.1110", measured near the point of detachment, was within specification.No other visible damage or defect was observed from the system.The device history record review was performed and the product passed all manufacturing inspections without non-conformances identified associated to the reported malfunction.There are manufacturing controls to avoid potential causes related to the detached tubing malfunction that include 100% visual inspection to the connection to verify the right application of adhesive, solvent or silicone was performed, qa sampling inspection to make sure all the samples manufactured comply with the requirements established, and a pull test by qa.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is evidence that supports or confirms the failure mode is associated to a manufacturing defect.
Event or Problem Description
As reported during use the vamp jr had blood backing up into the reservoir.No additional information was available.There was no patient injury.The device is available for evaluation.

• Brand Name: VAMP JR.
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23352108
• Report Number: 2015691-2025-08703
• Device Sequence Number: 9131558
• Product Code: KRA
• UDI-Device Identifier: 07460691944794
• UDI-Public: (01)07460691944794(17)260506(11)241205(10)66171783
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K896819
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 05/06/2026
• Device Model Number: VMP406
• Device Lot Number: 66171783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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 Sex: Unknown