MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MULTI-SAMPLE NEEDLE 22GX1

Catalog Number	DYNDMSN225
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lab reported that the needles' bevel goes around and around and they almost had a needle stick a few times; the customer also stated that when activating the needle guard it doesn't always catch, the needle has detached mid draw when switching tubes, and there is no white dot on the needle to indicate bevel up.Medline received one case of dyndmsn225 multi-sample needles in new condition, randomly selected 135 samples for visual and functional testing, and used a smiths medical venipuncture needle-pro safety device, which the customer advised they were using along with the multi-sample needles.The complaint was not confirmed; visual inspection revealed no manufacturing defects preventing the samples to work properly, the needles were screwed into the holders and no issues were experienced, and the luer mechanism safely secured and held the needles in place at all times.The 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.
Event or Problem Description
It was reported that "the bevel goes around and around.".

• Brand Name: MEDLINE
• Common Device Name: MULTI-SAMPLE NEEDLE 22GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945921
• Report Number: 1417592-2026-54158
• Device Sequence Number: 9499203
• Product Code: FMI
• UDI-Device Identifier: 30193489013331
• UDI-Public: 30193489013331
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/29/2026

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: DYNDMSN225
• Device Lot Number: 240220
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2024
• 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: 09/05/2024
• Initial Report FDA Received Date: 09/30/2026
• 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