MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HUBER INFUSION SET,NO Y-SITE,20G X 0.75

Catalog Number	HNX20075
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "needle came out from plastic base upon safety activation, and wing broke off on one.".
Additional Manufacturer Narrative
The account reported finding wing broke, and the complaint transcript stated that the needle came out from plastic base upon safety activation and the wing broke off on one.No sample or photo was received for the investigation; for investigation purposes, the division pulled samples to test, and testing of the huber needle safety mechanism found that of 29 samples, 1 safety mechanism failed, where immediately upon activation of the mechanism, the mechanism arms broke from the activation base and the needle was not retained.Based on the complaint details, sample evaluation, and investigation, the issue can be confirmed.The vendor was unable to determine the root cause of the issue and will be looking into improving the injection molding process; the complaint has been provided to the vendor for further evaluation and 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: HUBER INFUSION SET,NO Y-SITE,20G X 0.75
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50871812
• Report Number: 1417592-2026-49203
• Device Sequence Number: 10661538
• Product Code: PTI
• UDI-Device Identifier: 30197344039764
• UDI-Public: 30197344039764
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K251138
• 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): 09/23/2026

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: HNX20075
• Was Device Available for Evaluation?: No
• 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: 10/14/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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