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

Catalog Number	DYNDSBCN21G
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the luer is bending when we try to insert the tube and sometimes when the tube is removed, blood in the needle squirts out.".
Additional Manufacturer Narrative
The complainant reported the luer is bending when they try to insert the tube and sometimes when the tube is removed, blood in the needle squirts out.Medline received one case of samples, randomly selected 60 samples from the various lots and boxes of samples, tested using a phlebotomy simulation apparatus with one medline onguard blood collection holder per one needle and 3 vacutainer blood collection tubes, and after each completed collection inspected the luer and needles for any bending as well as making sure each safety mechanism was working properly.Among the 60 samples that were tested, medline observed no bending, no leaking, no failure of safety mechanism, or any other modes of failure; 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 21GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drieb; northfield, IL 60093--275
• MDR Report Key: 50715154
• Report Number: 1417592-2026-35772
• Device Sequence Number: 10640532
• Product Code: FMI
• UDI-Device Identifier: 10193489007879
• UDI-Public: 10193489007879
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/05/2026

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: 31823100001
• 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: 04/09/2025
• Initial Report FDA Received Date: 09/10/2026
• 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