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

Catalog Number	SYRSI193292Z
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we are having an issue with the.5 insulin needles.When they are putting it in the bottle and or taking it out they are bending.".
Additional Manufacturer Narrative
Customer reported an issue with the.5 insulin needles bending when putting it in the bottle and or taking it out.Investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 12 months; the vendor reviewed quality records and retained samples, including appearance inspection, simulated use, dhr review, inspection records, and final product inspection records.Sample/photo was not provided, and investigation results were not confirmed; retained sample inspection showed the needle tip was sharp, without burrs or bending, simulated use found no needle bending and no abnormal situations, and dhr inspection found no abnormalities and no deviations.Root cause was unable to determine; based on the review, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and there was no reported death or serious injury associated with this event.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: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50857298
• Report Number: 1417592-2026-48000
• Device Sequence Number: 15827049
• Product Code: FMF
• UDI-Device Identifier: 20888277657301
• UDI-Public: 20888277657301
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/22/2026

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: SYRSI193292Z
• Device Lot Number: 89723080001
• 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: 07/08/2024
• Initial Report FDA Received Date: 09/22/2026
• 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