MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 6.5", 0.7ML, NONBOND NF

Catalog Number	DYNDTC5077H
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that her items are defective.They are leaking, they also have brown & green stains inside tubing.
Additional Manufacturer Narrative
(b)(4).Yes no malfunction no 525 (tube) 2199 (no health consequences or impact) 4582 (no clinical signs, symptoms or conditions) 1120 (contamination) 4112 (analysis of information provided by user/third party), 4114 (device not returned) 4256 (malfunction observed without conclusive finding) 4315 (cause not established) unknown the account reported finding item is leaking; brown/green stains in tubing, and it was reported that the tubing was discarded and not used for patient care.A photo was received for our investigation; in the provided photo, one can clearly see some staining on the tubing, but the customer has not provided a sample for evaluation.Based on the complaint details, photo evaluation, and our investigation, the issue of "brown/green stains in tubing" can be confirmed and the issue of "item is leaking" cannot be confirmed.At this time, a root cause for the issue of "brown/green staining on tubing" cannot be identified; this complaint has been provided to the vendor for further evaluation, and the supplier quality team 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 EXT SET, 6.5", 0.7ML, NONBOND NF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866559
• Report Number: 1417592-2026-48479
• Device Sequence Number: 10691009
• Product Code: FPA
• UDI-Device Identifier: 10080196141883
• UDI-Public: 10080196141883
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/22/2026

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: DYNDTC5077H
• Device Lot Number: 23062C1482B
• Was Device Available for Evaluation?: Yes
• 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: 01/17/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown