MAUDE Adverse Event Report: ACCESSS VASCULAR, INC HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	MID-141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported pain and possible delay in receiving medication approximately 7 days after catheter placement.Potential occlusion as it was difficult to push fluids through catheter.Catheter removed and replaced with another catheter.Small pinhole leak found in removed catheter.
Additional Manufacturer Narrative
During investigation with actual returned device, a small kink was noted at the 3 cm marking.A small pinhole leak was noted at the 3 cm marking.No definitive root cause could be determined from the lot tracing and internal investigation.There were zero non-conformances identified during manufacturing.

• Brand Name: HYDROMID
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ACCESSS 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 ; 7815386594
• MDR Report Key: 23879155
• Report Number: 3021570645-2025-00027
• Device Sequence Number: 13167372
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: 00850030354358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K220772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 02/22/2026
• Device Model Number: MID-141
• Device Catalogue Number: 80H04104
• Device Lot Number: 03102503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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