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

Catalog Number	DYNDTNBCS23GZ
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	04/26/2024
Type of Reportable Event	Malfunction

• 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: felipe bifareti
• MDR Report Key: 50715529
• Report Number: 1417592-2026-35818
• Device Sequence Number: 13408369
• Product Code: FPA
• UDI-Device Identifier: 20888277680231
• UDI-Public: 20888277680231
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/06/2026

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: DYNDTNBCS23GZ
• Device Lot Number: 220501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2024
• 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: 04/26/2024
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown