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

Model Number	HYDROMID
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident description: the catheter was inserted on (b)(6) 2024.The following day, a nurse observed a leak and slight swelling at the insertion site during flushing.The nurse reported that they likely "pushed fairly hard attempting to flush it." the patient experienced tenderness 3 cm above the insertion site.The nurse was unable to obtain blood return and subsequently removed the catheter from the patient.Upon examination, a slight kink and fracture of the catheter were observed and reported to avi on (b)(6) 2024.The midline was replaced the next day in the same arm but a different vein and was functioning well at the time of the report.Device investigation: the catheter was returned to avi on october 15, 2024, for further investigation.An axial break was found at the 3 cm mark, and a kink was confirmed near the 3.2-3.6 cm mark.The catheter was fully patent.Upon cross-sectioning, an axial deformation was observed in the inner wall, resulting in a localized thin wall, which likely contributed to the break.Production and lot review: the lot number was provided by the complainant.A review of production records for that lot and associated lots revealed no nonconformances.Additionally, no other reports of issues with this lot or associated lots have been received by avi.Root cause analysis: potential causes of the break have been investigated, including consideration of damage by a guidewire during use and the review of production images of catheter cross-sections.However, no root cause has been identified.Without additional information, the root cause cannot be determined.
Event or Problem Description
Customer reported a fractured midline 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: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 20525241
• Report Number: 3015060232-2024-00021
• Device Sequence Number: 20829131
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: (01)00850030354358
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: 07/09/2025
• Device Model Number: HYDROMID
• Device Catalogue Number: 80H04104
• Device Lot Number: 03012404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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