MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SAFETY BLOOD COLLECTION NEEDLE 21GX1

Catalog Number	DYNDSBCN21G
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the customer drawing blood from a patient and blood leaking from the distal needle into the tube holder.".
Additional Manufacturer Narrative
The customer reported drawing blood from a patient and blood leaking from the distal needle into the tube holder; upon completing the draw, they noticed that blood was leaking into the tube holder.Medline received 5 onguard blood collection sets in new condition, randomly selected 20 samples, and performed a visual inspection and functional testing by inserting the needles into an iv injection pad.The visual inspection revealed no manufacturing or any other defects, the needles were able to draw the saline solution with no issues, no leaking was observed, and the safety mechanism was activated with no issues.The complaint was not confirmed, the recorded cause was not confirmed with received sample, and the samples worked as intended.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 21GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856114
• Report Number: 1417592-2026-47824
• Device Sequence Number: 21338690
• Product Code: FMI
• UDI-Device Identifier: 30193489007873
• UDI-Public: 30193489007873
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/22/2026

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: DYNDSBCN21G
• Device Lot Number: 05112007
• 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: 09/21/2023
• Initial Report FDA Received Date: 09/22/2026
• 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