MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROMID; INTRAVASCULAR CATHETER

Model Number	MID-141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned for evaluation.Two kinks in the catheter body were observed at the 10cm mark and at 12.5cm.A hole in one side of the 10cm marking observed.It is not certain if th ekink and hole are causal.
Event or Problem Description
Company contacted by nurse reporter regarding a hydromid catheter that allowed for infiltration of medication to upper right arm.A leak or rupture of the catheter body.The catheter was removed and replaced with no clinical impact to the patient.

• Brand Name: HYDROMID
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer (Section G): ACCESS VASCULAR, INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: scott blood ; 749 middlesex turnpike; billerica, MA 01821
• MDR Report Key: 25511099
• Report Number: 3021570645-2026-00006
• Device Sequence Number: 10502012
• Product Code: FOZ
• UDI-Device Identifier: 00850030354365
• UDI-Public: 00850030354365
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K220772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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 Model Number: MID-141
• Device Catalogue Number: 80H04104
• Device Lot Number: 03102502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown