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	Pain (1994)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report of a fractured midline.
Additional Manufacturer Narrative
The complainant reported that the midline catheter was removed on (b)(6) 2024 after being in place for four days.A fracture was observed upon removal.The complainant is a mobile provider and stated that she was not sure if the fracture was device-related or it was caused by the site maintaining the line using a small syringe and excessive force during line maintenance; however, the approach used to maintain the line is unknown.The line was returned to avi on 03 dec 2024.A break was observed at the 6.3 cm mark and indications of previous kinks in the line were observed at the 2.9 cm, 5.1 cm, and 7 cm marks.Stretched material at the location of the break indicated that the break was caused by internal pressure.Blood was found in the lumen from the point of the break (6.3 cm) to the tip of the catheter (13 cm), but the amount of blood did not occlude potential flow.The needless connector attached to the line to maintain line pressure and prevent incursion of blood was not the connector provided in the avi convenience kit.The review of the lot history record did not identify any nonconformances.The break in the line was confirmed, but a root cause 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: 20883548
• Report Number: 3015060232-2024-00028
• Device Sequence Number: 7921370
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: (01)00850030354358
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 12/09/2024

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: 07/09/2025
• Device Model Number: MID-141CM
• Device Catalogue Number: 80H04104
• Device Lot Number: 03012404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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