MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLD COLL SET, 23GX0.75", 7IN TUBING

Catalog Number	DYNDTNBC23G7Z
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there is a safety issue with how hard they are to slide the protective sleeve up on the used needle.Some are so hard to slide, that we cannot use the safety slide at all.".
Additional Manufacturer Narrative
The customer reported a safety issue with how hard the protective sleeve was to slide up on the used needle, and that some were so hard to slide that the safety slide could not be used at all.Medline received 1 box of blood collection sets in new condition, randomly selected 25 samples, and performed visual inspection and functional testing; the visual inspection revealed no manufacturing or any other defects, no excessive force was needed, and there were no noticeable defects or issues noted when activating the safety mechanism.The complaint was not confirmed, and the cause was documented as not confirmed with received sample.The samples worked as intended, and the division will continue to monitor the issue for trending.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: BLD COLL SET, 23GX0.75", 7IN TUBING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804750
• Report Number: 1417592-2026-43748
• Device Sequence Number: 20981759
• Product Code: FPA
• UDI-Device Identifier: 20193489010425
• UDI-Public: 20193489010425
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/16/2026

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: DYNDTNBC23G7Z
• Device Lot Number: 220501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2024
• 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: 10/03/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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