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

Model Number	PICC-142 CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a picc catheter that was fractured.
Additional Manufacturer Narrative
The complainant reported that the picc line was inserted on (b)(6) 2024 and received daily infusions at an outpatient clinic.Site records indicate that a chest x-ray was taken on (b)(6) 2024 to check the position of the line.No complications were noted on 25 feb 2024.On (b)(6) 2024, the patient's arm was swollen with pain and flushing.The line was removed.The complainant identified breaks at two locations in the line.The line was returned on 22 mar 2024 for investigation.No information about the product lot or other information was provided.Avi evaluated the line and identified leaks at the 6.0 cm and 6.5 cm marks.The leaks appear to be caused by clean cuts on the underside of where the line is marked.The cuts do not appear to be caused by design or manufacturing.The cause cannot be determined.In addition, the location of the securement device and amount of catheter outside the body is not in line with the instruction for use.

• 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: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 18998133
• Report Number: 3015060232-2024-00006
• Device Sequence Number: 8381085
• Product Code: LJS
• UDI-Device Identifier: 00850030354303
• UDI-Public: (01)00850030354303
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

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 Expiration Date: 12/07/2025
• Device Model Number: PICC-142 CM
• Device Catalogue Number: 80H01104
• Device Lot Number: 01152405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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: Other
• Patient Sex: Unknown