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

Model Number	MID-141CM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant noted that infusate was leaking from insertion site during procedure.A break in the catheter was observed once the catheter was removed.
Additional Manufacturer Narrative
Complainant reported there was infusate leaking from the insertion site.Catheter was replaced.Health professional noted a break in the catheter at removal.Product was not returned for review and patient condition at device removal was not described.

• Brand Name: HYDROMID
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM UNDER 30 DAYS
• Manufacturer (Section D): ACCESSS VASCULAR, INC; 749 middlesex turnpike; billerica MA 01821
• Manufacturer (Section G): ACCESSS VASCULAR, INC; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: scott blood ; 749 middlesex turnpike; billerica, MA 01821 ; 7815382025
• MDR Report Key: 22816330
• Report Number: 3015060232-2025-00021
• Device Sequence Number: 21008497
• Product Code: FOZ
• UDI-Device Identifier: 00850030354334
• UDI-Public: (01)00850030354334
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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 Model Number: MID-141CM
• Device Catalogue Number: 80H044104
• Device Lot Number: 04222503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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