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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Suspected deep vein thrombosis (dvt) post midline placement.
Additional Manufacturer Narrative
(b)(6) (rn at (b)(6) healthcare) reported to avi two cases of suspected dvt on the same day using the same lot of product.As a result, avi is submitting two mdrs.(this mdr) is being reported for suspected dvt for a male patient post-midline placement.A midline had been inserted in the patient's left upper arm on (b)(6) 2022 at an inpatient facility and required removal on the same day.(b)(6) was not able to view the ultrasound report and therefore was not able to confirm suspicion of dvt.(b)(6) noted that he had tried different methods for hydration, rather than follow the provided ifu.(b)(6) (rn, avi clinical field director) reinforced the importance of utilizing the correct method for hydration.The lot history records for the following lots were reviewed and did not reveal any anomalies or deviations that could have contributed to the complaint issue: 10122101, 11042102, 12092103, 11162103, 12162105, 11242103.

• 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 Contact: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 15474019
• Report Number: 3015060232-2022-00003
• Device Sequence Number: 2873538
• Product Code: FOZ
• UDI-Device Identifier: 00850030354020
• UDI-Public: 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

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: 02/23/2023
• Device Model Number: MID-141
• Device Catalogue Number: 80004004
• Device Lot Number: 11432076
• 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: 08/30/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male