MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLD COLL SET, 21GX0.75", PREATTACH H

Catalog Number	DYNDTNHBC21G
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when employee removed the butterfly needle from the vacutainer the needle remained in the tube.".
Additional Manufacturer Narrative
The customer reported receiving a medline blood collection set with a needle stuck in the tube, and there was no reported death or serious injury associated with this event.Medline received photographs and the defected sample by the customer as well as 7 boxes of unused product, and tested 40 random samples of the unused product by testing 4 vacutainer blood tubes on each blood collection set via a venipucture blood board.All 40 tested samples passed and still had their needle attached to the butterfly collection set; however, the photograph showed evidence of the needle no longer being attached to the end of the butterfly needle, and the complaint was confirmed.Cause was documented as cannot determine cause w/received sample, and the division will continue to monitor the issue for trending.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: BLD COLL SET, 21GX0.75", PREATTACH H
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50766416
• Report Number: 1417592-2026-40263
• Device Sequence Number: 9550281
• Product Code: FPA
• UDI-Device Identifier: 10193489013115
• UDI-Public: 10193489013115
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/14/2026

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: DYNDTNHBC21G
• Device Lot Number: 240801
• 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: 01/16/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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