MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BLD COLL SET, 21GX0.75", PREATTACH HLDR

Catalog Number	DYNDTNHBC21G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025 when disconnecting the tube from the blood collection device the "needle from the butterfly that goes into the tubes was sticking out of the top of the tube.".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 when disconnecting the tube from the blood collection device the "needle from the butterfly that goes into the tubes was sticking out of the top of the tube." the customer reported after the incident occurred the patient was "re-stuck" using a new device to finish blood collection.The customer did not report any serious injury related to the reported event.No additional information is available at this time.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.

• Common Device Name: BLD COLL SET, 21GX0.75", PREATTACH HLDR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21642429
• Report Number: 1417592-2025-00135
• Device Sequence Number: 7574101
• Product Code: FPA
• UDI-Device Identifier: 10193489013115
• UDI-Public: 10193489013115
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNDTNHBC21G
• Device Lot Number: 240801
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown