MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,25GX1.5

Catalog Number	SSN100257Z
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the luer lok function on these needles does not work 100% of the time" and "this has led to the needle remaining in our patients after injecting medication because the needle device un-screws from the syringe.".
Additional Manufacturer Narrative
The customer reported that the luer lok function on these needles does not work 100% of the time and this has led to the needle remaining in patients after injecting medication because the needle device un-screws from the syringe.Medline received 2 boxes of (b)(6) hypodermic safety needle in new condition, randomly selected 50 samples to perform visual and functional testing, attached the needles to bd 10ml syringes (b)(6), inserted them into the injection pad, and activated the safety cap.The visual inspection revealed no manufacturing defects preventing the samples to work properly, there were no indications of any needle breaking or being detached from the syringe, all needles stayed attached to the syringe, and the complaint was not confirmed.The samples worked as intended, and the cause was not confirmed with received sample.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,25GX1.5
• 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: 50773189
• Report Number: 1417592-2026-40541
• Device Sequence Number: 18571165
• Product Code: FMF
• UDI-Device Identifier: 20193489031994
• UDI-Public: 20193489031994
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/10/2026

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: SSN100257Z
• Device Lot Number: 89721110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2023
• 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: 01/18/2023
• Initial Report FDA Received Date: 09/15/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown