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

Model Number	MID-141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During investigation with actual returned device, it was noted that the catheter was sent in two parts, catheter body and suture wing.The catheter was cut t length at 11cm.Kinks were found at suture wing interface, luer hub/extension tube.No other kinks were found.No definitive root cause could be determined from the lot tracing and internal investigation.There were zero non-conformances identified during manufacturing.
Event or Problem Description
Nurse stated that the line would not flush.After some effort, the line was able to be flushed but a leak was found.Patient asked to return to healthcare site.Upon arrival, the dressing was saturated, and when removed, the catheter had separated from the hub outside the insertion site.

• Brand Name: HYDROMID
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ACCESSS 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 ; 7815386594
• MDR Report Key: 23982223
• Report Number: 3021570645-2025-00028
• Device Sequence Number: 18793863
• Product Code: FOZ
• UDI-Device Identifier: 00850030354365
• UDI-Public: 00850030354365
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K220772
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: 01/01/2026
• Device Model Number: MID-141
• Device Catalogue Number: 80H04104
• Device Lot Number: 09232407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown