MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,22GX1.5

Catalog Number	SSN100227Z
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the clear plastic cap instantly falls off when you remove it from the package.It also does not lock on when you try to replace it.In addition the black luer lock does not lock onto the syringe well.It has two tini threads to hold it onto the syringe vs a full ring that our previous needles have.".
Additional Manufacturer Narrative
The customer reported that the clear plastic cap instantly falls off when removed from the package, does not lock on when replaced, and the black luer lock does not lock onto the syringe well; the customer also reported a few safety close calls since switching to this needle.Investigation included review of the lot/serial number and recent complaint trends/scar activity, and the review of recent trend reports identified trends associated with needles coming off syringe but no trends for the loose safety cap.The complaint was not confirmed because no sample, photo, video, or other critical details were provided, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.The cause was recorded as unconfirmed defect, sample required to determine cause, and complaints will continue to be monitored with the complaint to be reopened if a sample, photo and/or additional information becomes available.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,22GX1.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947766
• Report Number: 1417592-2026-54483
• Device Sequence Number: 18516337
• Product Code: FMI
• UDI-Device Identifier: 20193489031949
• UDI-Public: 20193489031949
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/23/2026

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: SSN100227Z
• Device Lot Number: 8972306001
• 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: 12/07/2023
• Initial Report FDA Received Date: 09/30/2026
• 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