MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLOOD COLLECTION SET, 23GX0.75"

Catalog Number	DYNDTNBCS23G
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "two butterflies became disconnected while drawing a patient, the disconnect was with the blood tube not patient entrance site.".
Additional Manufacturer Narrative
The customer reported two butterfly issues during blood collection: in one event, "the whole rubber sheath along with the metal piece underneath the rubber sheath came out into the tube," and in another, "the rubber sheath and metal piece remained in her gold tube"; no serious injury, medical intervention, or follow-up care was reported, and the patient/user were reported as fine.No samples were received, but a photo was provided; medline ordered reserve stock from the same reported lot, randomly selected 25 samples, and performed visual inspection and functional testing, and the vendor performed internal investigation including dhr review, inspection records review, and retention sample testing.Medline confirmed the complaint based on the photos provided, while reserve stock testing worked as intended and the vendor found no abnormalities and could not confirm the complaint.The root cause was unable to be determined, 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: BLOOD COLLECTION SET, 23GX0.75"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50793463
• Report Number: 1417592-2026-42789
• Device Sequence Number: 9524911
• Product Code: FPA
• UDI-Device Identifier: 30888277680238
• UDI-Public: 30888277680238
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/15/2026

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: DYNDTNBCS23G
• Device Lot Number: 10:240501
• 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: 09/24/2024
• Initial Report FDA Received Date: 09/16/2026
• 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