MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SAFETY BLOOD COLLECTION NEEDLE 22GX1

Catalog Number	DYNDSBCN22G
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the safety device on the needle is popping off during use.".
Additional Manufacturer Narrative
The customer reported receiving a medline safety needle with the safety device popping off during use; according to the customer, during a normal venipuncture the patient had a painful experience from the stick due to the safety needle cover falling off during use, with no unintended needle stick outside of what was intended for the procedure and no serious injury, medical intervention, or follow-up care.Medline received one case of safety blood collection needles, randomly selected a total of 50 using samples from each box, used three vacutainer tubes with blood collection tube holders to simulate a multiple tube draw for each needle, then activated the safety locking mechanism and inspected for loose parts or inactivation of the safety device.All 50 needles passed with no parts falling off or misfiring of the safety device of any kind, all samples worked as intended, and the investigation results were not confirmed.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.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-SAFETY BLOOD COLLECTION NEEDLE 22GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50755158
• Report Number: 1417592-2026-39357
• Device Sequence Number: 13178661
• Product Code: FMI
• UDI-Device Identifier: 10193489007886
• UDI-Public: 10193489007886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182146
• 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: DYNDSBCN22G
• Device Lot Number: 31824060001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2025
• 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: 06/02/2025
• Initial Report FDA Received Date: 09/14/2026
• 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