MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5"

Catalog Number	SYRSI101292
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "these needles that¿s coming to jacksonville are defected.The safety is faulty you could stick yourself.".
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving medline safety insulin syringes with needle and shield that has a faulty safety; there was no reported death or serious injury associated with this event.Medline received 6 ea under the complaint of "safety is faulty," visually inspected the samples with no obvious signs of defect or damage, and tested all 6 ea by activating the safety and inspecting the needle for safety.The needle would not come out and the safety mechanism was working as intended; the complaint is not confirmed.During testing, 2 needles were only twisted half way, which might be what the customer is experiencing; the needle is secured and safe after fully twisting with the audible click, 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: DBQ-SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50694635
• Report Number: 1417592-2026-35031
• Device Sequence Number: 20327503
• Product Code: MEG
• UDI-Device Identifier: 10888277657298
• UDI-Public: 10888277657298
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231907
• 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: SYRSI101292
• Device Lot Number: 8972502000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/12/2025
• 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: 11/04/2025
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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