MAUDE Adverse Event Report: ACCESS VASCULAR INC. HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM

Model Number MID-141CM

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 02/12/2024

Event Type  Injury  

Event Description

Customer reported a midline catheter that was fractured.

Manufacturer Narrative

The complainant reported that the midline catheter was inserted without using a guidewire to stiffen the catheter.The iv rn who placed the catheter had no difficulty and initially had great blood return.Later that day, the floor rn reported difficulty flushing the line and no blood return.The iv rn returned and completed a dressing change and flushed the line, but still had no blood return.The floor rn flushed the line two times by the next morning but still had not blood return.The iv rn retracted the line 2 cm and changed the needleless connector and was able to flush the line and get a good blood return.Upon infusion, the patient reported pain.The line was removed, and the fracture was noticed.The catheter was returned to avi on 29 feb 2024 for investigation.The fracture was observed at the 8cm mark.Partial occlusions were observed distal (downstream) from the fracture.The fracture occurred axially along the catheter tube and had pressure induced stress/fatigue and stretching around the fracture.The cause of this excessive pressure cannot be determined.

• Brand Name: HYDROMID
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• 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: 18873957
• MDR Text Key: 337307560
• Report Number: 3015060232-2024-00005
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: (01)00850030354358
• 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: 03/11/2024

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
• Device Operator: Health Professional
• Device Model Number: MID-141CM
• Device Catalogue Number: 80H04104
• Device Lot Number: 12062301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2023
• 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