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

Catalog Number	SLIDEBR25G
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	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "after receiving a flash with the butterfly needle, i attached the needed blood tube to the needle holder and held both firmly as the blood tubes will pop off.The needle holder and the blood tube stayed safely in one hand, (the other hand was still holding the butterfly wings of the needle in the patient's arm), but the tube plug puncture needle in the needle seat popped out of the needle holder.The plug puncture needle is covered in a rubber sleeve that prevented contact with that needle.I thought it was user error and that i did not screw the needle holder on tightly and reattached the needle holder as tightly as i could.When i inserted the blood tube, it happened again and i quit that blood draw.".
Additional Manufacturer Narrative
The report states, "after receiving a flash with the butterfly needle, i attached the needed blood tube to the needle holder and held both firmly as the blood tubes will pop off.The needle holder and the blood tube stayed safely in one hand, (the other hand was still holding the butterfly wings of the needle in the patient's arm), but the tube plug puncture needle in the needle seat popped out of the needle holder.The plug puncture needle is covered in a rubber sleeve that prevented contact with that needle.I thought it was user error and that i did not screw the needle holder on tightly and reattached the needle holder as tightly as i could.When i inserted the blood tube, it happened again and i quit that blood draw." customer also reported, "when drawing an elderly patient using the listed 25-gauge butterfly needle, the connector from the needle tubing to the rubber sheathed needle for filling blood tubes disconnected with great force.It has been known that when you attach a blood tube to that area, the tube will need to be held firmly to prevent it popping off.As i held the screw on needle cover over the rubber sheathed needle and the tube firmly against that needle to fill the blood tube.The rubber sheathed needle was still attached to the needle in the patient's arm by the tubing.The rest of the setup was in my hand.Fortunately, the patient and i were not hurt by the flying rubber sheathed needle that popped off with a good amount of force.I stopped the draw and had to start over with another draw for the patient using a different needle.The patient did not have any injury from the draw and malfunction of the needle." 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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Common Device Name: SLIDE BLOOD COLLECTION SET, 25GX0.75
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804956
• Report Number: 1417592-2026-09962
• Device Sequence Number: 12910722
• Product Code: FMI
• UDI-Device Identifier: 10197344098798
• UDI-Public: 10197344098798
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K214075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SLIDEBR25G
• Device Lot Number: 31825100002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown