MAUDE Adverse Event Report: ACCESSS VASCULAR, INC HYDROMID; CATHTETER, VASCULAR ACCESS

Model Number	MID-251CM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Company representative was contacted by a customer to state that an inserted catheter was leaking infusate.The customer reported that the catheter was inserted a month ago.The floor staff called the iv team because the catheter was not flushing and leaking at the site as well as swelling near the insertion site and not flushing.Initially he felt that the line may have been damaged by staff on dressing change.A video taken by the customer showed a leak at the 0 cm mark.The customer reported that the catheter was discarded upon removal.

• Brand Name: HYDROMID
• Common Device Name: CATHTETER, VASCULAR ACCESS
• 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: 23077796
• Report Number: 3015060232-2025-00024
• Device Sequence Number: 19994720
• Product Code: FOZ
• UDI-Device Identifier: 00850030354426
• UDI-Public: (01)00850030354426(17)270520(10)06022516
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K251202
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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
• Device Model Number: MID-251CM
• Device Catalogue Number: FG-80H06102
• Device Lot Number: 06022516
• 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: 08/20/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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: Other
• Patient Sex: Unknown