MAUDE Adverse Event Report: ACCESS VASCULAR INC. HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM

Model Number	MID-141CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a midline catheter that was fractured.
Additional Manufacturer Narrative
The complainant reported that the midline catheter was inserted without using a guidewire to stiffen the catheter.The iv rn who placed the catheter had no difficulty and initially had great blood return.Later that day, the floor rn reported difficulty flushing the line and no blood return.The iv rn returned and completed a dressing change and flushed the line, but still had no blood return.The floor rn flushed the line two times by the next morning but still had not blood return.The iv rn retracted the line 2 cm and changed the needleless connector and was able to flush the line and get a good blood return.Upon infusion, the patient reported pain.The line was removed, and the fracture was noticed.The catheter was returned to avi on 29 feb 2024 for investigation.The fracture was observed at the 8cm mark.Partial occlusions were observed distal (downstream) from the fracture.The fracture occurred axially along the catheter tube and had pressure induced stress/fatigue and stretching around the fracture.The cause of this excessive pressure cannot be determined.

• Brand Name: HYDROMID
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• 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: 18873957
• Report Number: 3015060232-2024-00005
• Device Sequence Number: 9050130
• 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): 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2025
• Device Model Number: MID-141CM
• Device Catalogue Number: 80H04104
• Device Lot Number: 12062301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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