MAUDE Adverse Event Report: ACCESS VASCULAR. INC. HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	MID-141CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the catheter was inserted in the brachial vein of the patient on (b)(6) 2025 and removed on (b)(6) 2025 due to an inability to flush.No other patient impact was reported.Upon removal, a rupture was identified in the line.On 28 january 2025, the catheter was returned to avi for evaluation.The catheter had been trimmed to the 11 cm marking for the procedure.The evaluation identified a kink and rupture at the 4.5 cm mark characterized as a small pinhole opening that stretched axially.Additional kinks were observed at the 2.8 cm and 6.5 cm marks.No breaks were present at these locations.The catheter remained patent with no occlusions.A review of the lot history revealed no non-conformances associated with the production lot.The cause of the rupture could not be identified from the available information.
Event or Problem Description
A kink and a rupture in the midline catheter.

• Brand Name: HYDROMID
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS 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: 21327238
• Report Number: 3015060232-2025-00003
• Device Sequence Number: 8128819
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: (01)00850030354358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203069
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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
• Device Expiration Date: 02/28/2026
• Device Model Number: MID-141CM
• Device Catalogue Number: 80H04104
• Device Lot Number: 09122402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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