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

Model Number MID-141CM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The complainant reported that the midline catheter had kinked and that when it was removed a hole in the catheter was identified.The complainant provided an image showing the hole.Avi has requested that the catheter be returned for investigation, but the catheter has not been returned and the lot number has not been reported.No further investigation is possible.

Event Description

Report of break in catheter.

• Brand Name: HYDROMID
• Type of Device: 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: 19116128
• MDR Text Key: 340279471
• Report Number: 3015060232-2024-00007
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00850030354211
• UDI-Public: (01)00850030354211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Model Number: MID-141CM
• Device Catalogue Number: 80004104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other