MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ALLERGY TRAY, 27GX0.5", 1 ML 25 SYR/

Catalog Number	SYRA101272
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needles are dull" and "the needle are not puncturing effectivly.".
Additional Manufacturer Narrative
The customer reported that the needles were dull, the needle are not puncturing effectivly, and patients were uncomfortable receiving shots; the facility also stated that patients expressed and complained of pain during and after their injections.Medline received 1 case of medline allergy syringe trays in new condition, randomly selected 30 samples for visual inspection and functional test, inserted the needles into a training pad using different angle points and force, and filled and flushed the syringes to different levels using a training vial.The visual inspection revealed no manufacturing or any other defects, all 30 samples tested penetrated without indications of dulled needles, there were no indications of needles bending or detaching from their hub, and there were no indications of leaking fluids from either the plunger or the needles¿ hub.The complaint was not confirmed; the cause code was not confirmed with received sample, the samples worked as intended, and no additional actions are required at this time.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: DBD-ALLERGY TRAY, 27GX0.5", 1 ML 25 SYR/
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50841147
• Report Number: 1417592-2026-46280
• Device Sequence Number: 10278355
• Product Code: FMF
• UDI-Device Identifier: 20888277654089
• UDI-Public: 20888277654089
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K113091
• 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): 09/18/2026

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: SYRA101272
• Device Lot Number: 221101
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/27/2023
• 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: 08/29/2023
• Initial Report FDA Received Date: 09/21/2026
• 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