MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,18GX1.5

Catalog Number	SSN100187Z
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the plastic caps fall off when they are opened and can fall off prior to giving the injections.".
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving medline hypodermic safety needles where the safety cap was coming loose during use; there was no reported death or serious injury associated with this event.Medline received 1ea hypodermic safety needle in new condition, ordered reserve stock, and randomly selected 20 samples plus the original sample to perform visual and functional inspection.During visual inspection, no indications of any manufacturing defects were seen, and during testing the clear safety caps stayed firmly attached to the needle and did not come off unless physically removed; the complaint was not confirmed.No root cause was identified, the samples worked as intended, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.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: NEEDLE,HYPODERM,SAFETY,18GX1.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754506
• Report Number: 1417592-2026-39230
• Device Sequence Number: 21165483
• Product Code: FMI
• UDI-Device Identifier: 10193489031874
• UDI-Public: 10193489031874
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K213054
• 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): 09/09/2026

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: SSN100187Z
• Device Lot Number: 89724040001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2025
• 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: 04/04/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown