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

Model Number	MID-142CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a kink and fracture in a midline.
Additional Manufacturer Narrative
The complainant reported that the midline catheter was inserted on (b)(6) 2024, they found a kink and a fracture, which led to the removal of the midline.There was no report of clinical impact to the patient.The line was replaced to complete the treatment.On (b)(6) 2025, the line was returned to avi and evaluated.Avi identified a visible opening at 2.2cm (3.2cm from the end of the suture wing) and kinks at 4.1cm, 4.5cm, and 5.7cm.The opening was perpendicular to the length of the catheter tube.There was no evidence of catheter material stretching and pressurization was not a factor in forming the opening.As part of the investigation, the sample was cross-sectioned and the walls around the opening appeared to be uniform.The opening resembled a slit from the 7 o'clock to 12 o'clock position along the left side of the catheter.A review of the lot history revealed no nonconformance's associated with the production lot.A mechanism that would cause the opening could not be identified from the available information and no root cause could be determined.

• 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: 21258420
• Report Number: 3015060232-2025-00002
• Device Sequence Number: 20893883
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: (01)00850030354358
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K203069
• 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): 01/28/2025

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: MID-142CM
• Device Catalogue Number: 80H04101
• Device Lot Number: 10282405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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: Female