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

Model Number	MID-141
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a ruptured midline.
Additional Manufacturer Narrative
On (b)(6) 2023, (b)(6) from rgv piccs contacted his avi sales representative to let him know he had experienced issues with midlines.On (b)(6) 2023, (b)(6) had a phone conversation with the avi clinical field director to discuss the issues.During this call, (b)(6) reported that a midline, which was being used for antibiotics, had ruptured approximately two months prior.The line was replaced, and he did not receive any further calls regarding the patient.He confirmed that the line was hydrated per the provided ifu, but noted that he did not have any documentation to provide dates, lot numbers, or other details.No photos or videos were taken.The device was discarded and therefore not available to be returned to avi for further analysis.A review of manufacturing records is not applicable, as the lot number was not provided.With the limited information provided, avi is unable to conduct further investigation.Root cause cannot be established.

• 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: 18475569
• Report Number: 3015060232-2024-00001
• Device Sequence Number: 15189523
• Product Code: FOZ
• UDI-Device Identifier: 00850030354020
• UDI-Public: (01)00850030354020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

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 Model Number: MID-141
• Device Catalogue Number: 80004004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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