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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) (nurse manager, iv therapy services at (b)(6) hospital) texted the avi clinical field director on (b)(6) 2023 to notify him of a leaking midline device.(b)(6) provided additional information to the avi complaints team via e-mail: the midline was inserted on (b)(6) 2023 for "all things iv" due to the patient's poor venous access.No power injections were performed.A few ct scans were done, but without contrast.(b)(6) team is required to change the needleless connector and flush the device during each dressing change.During one of the dressing changes, (b)(6) team discovered a small hole, visible to the human eye, in the tubing located "just after the connector hub." note that the hole was not in the hydromid material.The midline was removed on (b)(6) 2023 (dwell time of 14 days).The patient did not require any further iv access so there was no impact to the patient.(b)(6) team did not take any photos of the defect.The tubing noted is referring to the catheter extension tube, which is manufactured by cutting sections of extension tube extrusions (purchased from an approved supplier and inspected per avi's internal quality inspection plan) into 63mm length sections.This results in a clear, tecothane tubing that connects the suture wing to the luer hub.The lot number provided (11473239) is assigned by avi's approved contract manufacturer for kitting.This finished good lot contained catheters from six different avi catheter lot numbers: #01052302, #12222205, #01162306, #12132202, #01252308, and #02162302.For this investigation, all six lhrs were reviewed, and no discrepancies were identified that could potentially impact the extension tubes.Since the dwell time was 14 days before the defect was found and it was actively being used by the access team, it can be concluded that the extension tube did not have a hole until sometime after the insertion of the device.Without photos of the defect or a return of the device, avi is not able to determine a potential root cause.
Event or Problem Description
Customer reported a midline with a leak in the extension tube.

• 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: 17404501
• Report Number: 3015060232-2023-00008
• Device Sequence Number: 5837659
• 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 Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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: 02/11/2024
• Device Model Number: MID-141CM
• Device Catalogue Number: 80004104
• Device Lot Number: 11473239
• 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: 06/27/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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