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	Inflammation (1932)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant reported that she was just placing a midline and was not able to advance the catheter past the 6cm mark.She placed the guidewire back in the midline, felt some resistance, saw a bulge under the patient's skin and removed the line.Upon removal, she identified that the guidewire had punctured the catheter and the patient experienced a hematoma, which was addressed by holding pressure to the site.The complainant did not provide the lot number for the catheter and did not return the catheter or guidewire for investigation.Because the catheter was not returned for investigation, the cause of this issue could not be determined.
Event or Problem Description
The user pierced the catheter with the guidewire.

• 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: 19776449
• Report Number: 3015060232-2024-00015
• Device Sequence Number: 8115724
• Product Code: FOZ
• UDI-Device Identifier: 00850030354211
• UDI-Public: (01)00850030354211
• 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: 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): 07/18/2024

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 CM
• Device Catalogue Number: 80004104
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/18/2024
• 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: Unknown