MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLOOD COLLECTION SET, 25GX0.75"

Catalog Number	DYNDTNBCS25G
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they are coming unscrewed really each from our hubs while we are drawing patients or not screwing on them at all.".
Additional Manufacturer Narrative
The customer reported receiving a medline blood collection set that was coming unscrewed from hub during use, and according to the facility, ¿a phlebotomist was attempting to draw a pediatric patient, they went to pop a tube on the needle, and it separated from the hub¿; the staff member ¿reattached the hub¿ and ¿there was no patient impact¿ as they were able to ¿make it work.¿ at this time, a sample was not received for investigation, and no further action was taken since medline was not able to investigate the sample.The complaint was not confirmed.A root cause was not identified because a sample was required to determine cause; 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: BLOOD COLLECTION SET, 25GX0.75"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50713483
• Report Number: 1417592-2026-35648
• Device Sequence Number: 10005404
• Product Code: FPA
• UDI-Device Identifier: 30888277680245
• UDI-Public: 30888277680245
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151991
• 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): 09/05/2026

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: DYNDTNBCS25G
• Was Device Available for Evaluation?: No
• 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: 12/10/2024
• Initial Report FDA Received Date: 09/10/2026
• 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