MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ BLD COLL SET, 23GX0.75"", PREATACH H

Catalog Number	DYNDTNHBC23G
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had a medline butterfly device needle (the needle in the hub), come out of the hub today (on (b)(6) 2024) and blood began running into the patient¿s lap.It looks like the plastic on the threaded part of the hub broke.".
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving a medline blood collection set where its needle broke off and started leaking during use; the facility stated the patient was cleaned up and the needle was disposed in the sharps container.At this time, a sample was not received for investigation; investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 12 months, and the vendor was notified.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo.Based on the review of the details provided for the complaint investigation, medline is unable to confirm the complaint issue or that the product failed to meet specifications.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 BLD COLL SET, 23GX0.75"", PREATACH H
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdulrahim ghaffar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50758779
• Report Number: 1417592-2026-39748
• Device Sequence Number: 15793141
• Product Code: FPA
• UDI-Device Identifier: 30193489013126
• UDI-Public: 30193489013126
• 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): 09/14/2026

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: DYNDTNHBC23G
• Device Lot Number: 240501
• 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: 11/04/2024
• Initial Report FDA Received Date: 09/14/2026
• 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