MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SAFETY TUBE HOLDER, BLOOD COLLECTION

Catalog Number	DYNDSBCHLDR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needle bent trying to engage the safety and the safety will not stay engaged.".
Additional Manufacturer Narrative
The customer reported this was a used needle and that the needle bent trying to engage the safety and the safety will not stay engaged; no injuries were reported.Samples were not received for investigation; however, a video was provided that showed the safety not working on a bent needle, and the video showed a used tube holder with a blood collection needle clearly bent.The complaint was confirmed, and the investigation results were unconfirmed.Because the needle itself was bent, the safety could not properly engage; without additional samples, it is hard to identify what caused the defect.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: SAFETY TUBE HOLDER, BLOOD COLLECTION
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50731903
• Report Number: 1417592-2026-36780
• Device Sequence Number: 10599741
• Product Code: FMI
• UDI-Device Identifier: 30193489008429
• UDI-Public: 30193489008429
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K172763
• 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): 09/08/2026

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: DYNDSBCHLDR
• 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: 07/16/2024
• Initial Report FDA Received Date: 09/11/2026
• 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