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

Model Number	MID-141 CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant reported that the midline was inserted on (b)(6) 2024 and was removed on 11 april 2024 due to observed infiltration.The line was not replaced.No patient harm was reported.The line was returned to avi for investigation.A kink was observed at 4cm from the suture wing tip.A leak point was identified 90 degrees from the kink.The lot history records were reviewed and no nonconformances were identified.The root cause of the kink and break in the line could not be determined.
Event or Problem Description
Customer reported a break in a midline.

• 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 ; 7815386594
• MDR Report Key: 19279284
• Report Number: 3015060232-2024-00009
• Device Sequence Number: 6320814
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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-141 CM
• Device Catalogue Number: 80H04104
• Device Lot Number: 01162411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (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