MAUDE Adverse Event Report: ACCESSS VASCULAR, INC HYDROPICC

Model Number	FG-80H02104
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The picc was placed at a rehab center.After approximately 10 days on indwelling, patient was transported to hospital for poor blood flow.Patient underwent ultrasound and a possible kink was identified.Picc line was removed and a tear in the catheter was observed at 16cm line.Patient fine after picc removal and replacement.

• Brand Name: HYDROPICC
• Common Device Name: HYDROPICC
• 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 ; 7825386594
• MDR Report Key: 22957616
• Report Number: 3015060232-2025-00023
• Device Sequence Number: 8453338
• Product Code: LJS
• UDI-Device Identifier: 00850030354334
• UDI-Public: 00850030354334
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213550
• 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,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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 Expiration Date: 02/28/2026
• Device Model Number: FG-80H02104
• Device Lot Number: 03072517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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; Other
• Patient Sex: Unknown