MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-SYR W/NDLE,SAFETY,INSLN,0.5ML,29GX0.

Catalog Number	SYRSI193292
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a nurse got stuck by the needle because the safety part didn't stay closed on the needle right.".
Additional Manufacturer Narrative
The customer reported receiving a medline safety needle insulin 0.5ml that didn¿t successfully activate safety mechanism and reported that a nurse got stuck by the needle because the safety part didn't stay closed on the needle right.The sample(s) were marked received by medline on (b)(6) 2026, and storage, mailing room, and various labs were periodically checked for this sample.After 5 months the sample still could not be located, the complaint was marked not confirmed, and medline was not able to investigate it.Sample was required to determine cause; no trends were identified for the specified material number and its corresponding defect type, and there has been no change to the reportability decision associated with this complaint.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: DBQ-SYR W/NDLE,SAFETY,INSLN,0.5ML,29GX0.
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50692095
• Report Number: 1417592-2026-34797
• Device Sequence Number: 18555292
• Product Code: MEG
• UDI-Device Identifier: 10888277657304
• UDI-Public: 10888277657304
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: SYRSI193292
• Device Lot Number: 89725020003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2026
• 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: 01/15/2026
• Initial Report FDA Received Date: 09/09/2026
• 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