MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-SYR W/NDLE,SAFETY,22GX1.5, 3ML

Catalog Number	SSN103227Z
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the nurses say it does feel like the needle is \"dragging\"" and "they have always complained about the safety part popping off".
Additional Manufacturer Narrative
The reporting facility indicated that the needle is "dragging" and that they have had issues where the "safety part" of the needle is "popping off"; the customer also stated that patients have been complaining about the shots hurting where they typically have not.A sample was not received for investigation; investigation included review of the lot/serial number and recent complaint trends/scar activity, and the vendor's internal investigation included dhr review, inspection records review, and retained sample inspection.The complaint was not confirmed, and no root cause has been discovered.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications; if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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,22GX1.5, 3ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50846447
• Report Number: 1417592-2026-46961
• Device Sequence Number: 15933531
• Product Code: FMI
• UDI-Device Identifier: 20193489037897
• UDI-Public: 20193489037897
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/21/2026

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: SSN103227Z
• Device Lot Number: 89723030002
• 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: 01/04/2024
• Initial Report FDA Received Date: 09/21/2026
• 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