MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ROBOTIC PACK

Catalog Number	DYNJ56511C
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "every pack they have contains a faulty 22g safety needle.The safety flops down when they are trying to draw up.".
Additional Manufacturer Narrative
The account reported finding a defective safety needle, and cookeville clinical staff said the safety mechanism flops around when they are drawing up into the syringe.A sample was received; medline received a bag full of needles still sealed inside of its vendor packaging, observed no visual defects or damage to the component, performed functional testing, reviewed the pack's production record, and reviewed the finished good pack build.Functional testing of the component did exhibit the safety dropping; however, this did not affect use of the item and is the intended functionality, and the component was made to specification.Based on this, the root cause is considered customer preference, and the supplier quality team will monitor this issue for trending purposes.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-ROBOTIC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854851
• Report Number: 1417592-2026-47602
• Device Sequence Number: 15936719
• Product Code: LRO
• UDI-Device Identifier: 40195327326280
• UDI-Public: 40195327326280
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/21/2026

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: DYNJ56511C
• Device Lot Number: 23EBC738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2023
• 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: 07/25/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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