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	Inflammation (1932)
Date of Event	06/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant reported a break in a midline catheter after power injection was used for a ct angiogram.The catheter had been in place for three days.The patient experienced swelling and pain in the arm.The catheter was returned for investigation.The investigation identified a break at the 3.5cm mark, indications of kinks at the 4.5cm and 15.2cm marks, and an occlusion within the catheter at the 19.5cm mark.There was no evidence suggesting a structural or manufacturing defect.The root cause of the kinks and occlusion could not be determined.
Event or Problem Description
Report of a break in a catheter.

• 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: elizabeth haines ; 749 middlesex turnpike; billerica, MA 01821 ; 9785966862
• MDR Report Key: 19722506
• Report Number: 3015060232-2024-00014
• Device Sequence Number: 8190530
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: (01)00850030354358
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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: 11/16/2025
• Device Model Number: MID-141CM
• Device Catalogue Number: 80H04104
• Device Lot Number: 04242401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown