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

Catalog Number	SYRSI101292
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they are "hard to activate the safety sheath- they feel locked and require a bit more force than staff are used to.".
Additional Manufacturer Narrative
The customer reported receiving medline safety insulin syringes with needle for which the safety was not working during use and described the issue as hard to activate the safety sheath, feeling locked, and requiring more force than staff are used to; there was no reported death or injury associated with this event.Medline received 1 box in new condition and randomly selected 20 samples to perform visual and functional testing; the visual inspection revealed no manufacturing or defects preventing the samples from working as intended, and functional testing included moving the safety shield forward to cover the needle, locking it until an audible snap was heard, and attempting to unlock the safety shield.The complaint was not confirmed, no issues were experienced during testing, no excessive force was needed, and the samples worked as intended.Based on the review of the complaint investigation, 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: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50912874
• Report Number: 1417592-2026-51765
• Device Sequence Number: 5804172
• Product Code: MEG
• UDI-Device Identifier: 10888277657298
• UDI-Public: 10888277657298
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/25/2026

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: 89725020001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2025
• 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: 06/25/2025
• Initial Report FDA Received Date: 09/28/2026
• 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