MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-CEDIV EXT SET,6.5,1.1ML, M LUERLOCK,

Catalog Number	DYNDTB5077
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	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the hook up is also smaller and more difficult to connect.".
Additional Manufacturer Narrative
The account reported finding difficult to connect; the complaint also stated, "the 2 clients we used the new ones on today both blew the vein." no sample or photo was received for the investigation, finished good production records were reviewed by notifying the manufacturer and requesting a completed review of the production records, and finished good trending was reviewed with 0 additional reported complaints for this issue in the last 24 months.Based on the complaint details and evaluation, the complaint is not confirmed, and the investigation was limited without receipt of the physical sample or detailed photographic evidence from the customer.The cause was documented as sample required to determine cause, and the division 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: DBQ-CEDIV EXT SET,6.5,1.1ML, M LUERLOCK,
• 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: 50899080
• Report Number: 1417592-2026-51103
• Device Sequence Number: 14959081
• Product Code: FPA
• UDI-Device Identifier: 10197344098651
• UDI-Public: 10197344098651
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K242126
• 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): 09/24/2026

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: DYNDTB5077
• Device Lot Number: BQ250456601
• 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: 12/09/2025
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown