MAUDE Adverse Event Report: ACCESS VASCULAR. INC. HYDROPICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	PICC-142CM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2025, the complainant reported a leak in a catheter occurred on (b)(6) 2025, but provided no information about the type of catheter, the details of the event, or the lot number.No information was provided about the patient condition.Avi anticipates that the catheter will be returned for evaluation.
Event or Problem Description
Report of a break in the catheter.

• Brand Name: HYDROPICC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ACCESS VASCULAR. INC.; 749 middlesex turnpike; billerica 01821
• Manufacturer (Section G): ACCESS VASCULAR. INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: scott blood ; 749 middlesex turnpike; billerica 01821 ; 7815386594
• MDR Report Key: 22351201
• Report Number: 3015060232-2025-00018
• Device Sequence Number: 11987308
• Product Code: LJS
• UDI-Device Identifier: 00850030354303
• UDI-Public: (01)00850030354303
• 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 Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: PICC-142CM
• Device Catalogue Number: 80H01104
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (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: Other
• Patient Sex: Unknown