MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV ADMIN SET, 60DRP, 2 NF PORTS, 96"

Catalog Number	DYNDTN0512
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Other
Event or Problem Description
It was reported that "i used this tubing on a client, and the fluid did not stop infusing automatically.It continued to flow in even when the bag was empty, where it could potentially pull in air to the vein.".
Additional Manufacturer Narrative
The customer reported that during an infusion with this tubing, the iv was open to gravity, not on a pump; when the bag was completely empty, it was immediately clamped off and there was no fluid left in the tubing.A photo and a sample were received for investigation, but the sample was either lost or misplaced; the division pulled 1ea from inventory for testing, connected it to a saline bag, and left the saline bag to empty completely, observing that once the saline bag emptied, the drip chamber of the iv set also emptied completely and a small amount of residual liquid remained in the tubing.Based on the complaint details, sample evaluation, and investigation, the issue can be confirmed.The vendor has been notified of the issue, and the pulled sample will be sent to the vendor for further evaluation to determine root cause; supplier quality will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: IV ADMIN SET, 60DRP, 2 NF PORTS, 96"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854686
• Report Number: 1417592-2026-47560
• Device Sequence Number: 18518613
• Product Code: FPA
• UDI-Device Identifier: 40884389714783
• UDI-Public: 40884389714783
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: DYNDTN0512
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown