MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-IV ADMIN SET, 15DRP, 3 NF PORTS, 109

Catalog Number	DYNDTN1545
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there have been cracks in the portion of the tubing that connects to the iv catheter.After tightly connecting the tubing to the iv, there has been a visible leakage of blood or iv fluids, leaking onto the sheets.".
Additional Manufacturer Narrative
The customer reported issues with iv gravity sets, including cracks in the portion of the tubing that connects to the iv catheter and visible leakage of blood or iv fluids after tightly connecting the tubing to the iv.Medline quality received 1 ea for evaluation, and functional and visual inspection was conducted with the provided sample.It was found that the item functions normally, no issues with the leakage have been identified, and the complaint cannot be confirmed as no issues have been found.No root cause was identified; a retrospective review of the past two years indicated that there have been no prior complaints in regard to this issue, and the division will continue to monitor this issue for trending.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: DBD-IV ADMIN SET, 15DRP, 3 NF PORTS, 109
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853418
• Report Number: 1417592-2026-47352
• Device Sequence Number: 13136127
• Product Code: FPA
• UDI-Device Identifier: 20080196760029
• UDI-Public: 20080196760029
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNDTN1545
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2024
• 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: 08/22/2024
• 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