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

Catalog Number	DYNDSBCN22G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this is the 2nd time this account has encountered needle sticks with these safety needles" and "they decided to give them a try again last month and immediately had another finger stick.".
Additional Manufacturer Narrative
The customer reported receiving a medline blood collection needle that was causing needle sticks during use; according to the customer, when attempting to close the safety needle after the needle was used on a patient, the phlebotomist was "stuck." the customer reported labs were drawn after the incident "to check for diseases," and did not report any positive results from the labs, serious injury, medical intervention, or follow up care related to the reported incident.At this time, a sample(s) was not received for investigation; however, a lot number/serial number was recorded, and the investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 12 months.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo; the cause was unconfirmed, and the division has been informed and will continue to monitor trends.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 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803422
• Report Number: 1417592-2026-43472
• Device Sequence Number: 20995909
• Product Code: FMI
• UDI-Device Identifier: 30193489007880
• UDI-Public: 30193489007880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/16/2026

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: 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: 01/02/2025
• Initial Report FDA Received Date: 09/17/2026
• 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