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

Model Number	MID-141CM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a midline that was found to have a hole in the catheter wall after removal.
Additional Manufacturer Narrative
On (b)(6) 2023, (b)(6) of (b)(6) hospital notified the avi complaints department that he had a midline that was infiltrated and had to be removed.Upon removal, it was noted to have a hole in the catheter wall, about 3-4 centimeters from the catheter hub.He provided a photo (see attachment 1), but the line was not saved for return to avi.In a follow-up e-mail on 18 jan 2024, (b)(6) stated that his team had difficulty with flushing and blood return post-insertion and that it "appeared positional." the line was then "retracted" at one point, but the patient's arm appeared swollen, so the line was removed.The photo provided shows a visible defect in the catheter wall, however, it's not possible to further investigate the cause without return of the device.Lee confirmed that it was inserted per the ifu.Their protocol is to flush every 12 hours, however, he was unable to confirm that the flushing occurred as saline flushes are not documented on the emar (electronic medication administration record).The lot number provided by lee, #10262301, was determined to be incorrect.This corresponds with a catheter lot number that has not yet shipped from avi.Hartford hospital has received several lots of fg 80004104 kits, so the actual lot number cannot be determined.An lhr review is not applicable.With the limited information provided and without return of the device, avi is unable to determine a root cause.

• 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: 18566786
• Report Number: 3015060232-2024-00002
• Device Sequence Number: 8123944
• Product Code: FOZ
• UDI-Device Identifier: 00850030354211
• UDI-Public: (01)00850030354211
• 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 Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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-141CM
• 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: 12/26/2023
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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