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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report of a fractured line.
Additional Manufacturer Narrative
On 26 march 2025, the complainant reported breaks in a single-lumen picc line.There was no report of clinical impact to the patient.The line was returned to avi and the breaks were confirmed.The lot number for the device was not provided but lot history records were reviewed, based on shipping records, and there was no evidence of nonconformance's during production that would have contributed to the issue.Due to limited information provided by the complainant about the event, a root cause could not be determined, and no further investigation is possible.

• 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 MA 01821
• Manufacturer (Section G): ACCESS VASCULAR. INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: scott blood ; 749 middlesex turnpike; billerica, MA 01821 ; 9787295978
• MDR Report Key: 21893104
• Report Number: 3015060232-2025-00012
• Device Sequence Number: 12802430
• 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: K193015
• 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): 04/23/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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