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	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report of a midline catheter break near the suture wing.
Additional Manufacturer Narrative
The complainant reported that the midline was inserted on (b)(6) 2024 and removed on (b)(6) 2024 due to a break at the suture wing tip.The line had been installed at the complainant's facility, but the patient was discharged to a skilled nursing facility.As a result, the complainant had limited information regarding the maintenance of the midline.When the break was identified, the line had separated from the catheter hub and was removed using clamps.The line was returned to avi on 20nov2024 for evaluation.The evaluation identified that the line was broken approximately 14mm inside the suture wing.The line appeared to be dehydrated.Potential causes of dehydration include ineffective hydration, locking, and dressing of the catheter.A root cause of the dehydration and break could not 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: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 20783314
• Report Number: 3015060232-2024-00026
• Device Sequence Number: 5068886
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: (01)00850030354358
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 11/25/2024

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-141CM
• Device Catalogue Number: 80H04104
• Device Lot Number: 08202406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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
• Patient Sex: Unknown