MAUDE Adverse Event Report: Access Vascular, Inc. HydroPICC; Intravascular catheter

Model Number	PICC-142
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Nurse reported that a home care patient had a picc line removed due to infection.There were no clots or occlusions reported.Patient was admitted to hospital with a fever.Patient was placed on antibiotics, picc removed until cultures are negative for 72 hours and then another line was placed.There are no further details on the patient.Condition.

• Brand Name: HydroPICC
• Common Device Name: Intravascular catheter
• Manufacturer (Section D): Access 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 ; +1(781)538-6594
• MDR Report Key: 50463038
• Report Number: 3021570645-2026-00015
• Device Sequence Number: 10198277
• Product Code: LJS
• UDI-Device Identifier: 00850030354297
• UDI-Public: (01)00850030354297(17)271028(10)03132601
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K243941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PICC-142
• Device Catalogue Number: FG-80H01102
• Device Lot Number: 03132601
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• 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; Hospitalization
• Patient Sex: Unknown