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

Catalog Number	DYNDSBCN21G
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when they movethe safety cover to the sde of the device, t pulls the cap off the needle before they are reay ti remove it.The rubber over the needle that fits in the blood tube holder is too rigid and difficult to hold a blood collection tube on.The resistance from the rubber pushes the tube off the needle unexpectedly.".
Additional Manufacturer Narrative
The reporter described that the safety cover pulls the cap off the needle before they are ready to remove it, and the rubber over the needle that fits in the blood tube holder is too rigid and difficult to hold a blood collection tube on.A sample(s) was not received for investigation, and the investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 12 months; per vendor, through internal investigation, including dhr review and inspection records review, no abnormalities were found, and 20 retain samples were tested.The investigation results were unconfirmed, and the complaint could not be confirmed.The cause code was sample required to determine cause, and 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: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50805317
• Report Number: 1417592-2026-43838
• Device Sequence Number: 18777658
• Product Code: JKA
• UDI-Device Identifier: 30193489007873
• UDI-Public: 30193489007873
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/17/2026

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: 31823050001
• 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: 05/30/2024
• 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