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

Model Number	PICC-142CM
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 (b)(6) 2025.A video taken by the customer showed a leak at the 5cm mark.The catheter was removed with no further consequences to the patient.The customer reported that the catheter was discarded upon removal.

• Brand Name: HYDROPICC
• 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: 23085749
• Report Number: 3015060232-2025-00025
• Device Sequence Number: 9702320
• Product Code: LJS
• UDI-Device Identifier: 00850030354372
• UDI-Public: (01)00850030354372(17)260930(10)01282501
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K243941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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 Expiration Date: 09/30/2026
• Device Model Number: PICC-142CM
• Device Catalogue Number: FG-80H01102
• Device Lot Number: 01282501
• 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: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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