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

Catalog Number	DYNDTNBC23G7Z
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needles are not going back into the safety sleeve.".
Additional Manufacturer Narrative
The reported issue was needles not going into safety sleeve.Medline received 1 box of blood collection sets in new condition, randomly selected 25 samples, and performed a visual inspection and functional testing.The complaint was not confirmed; the visual inspection revealed no manufacturing or any other defects, there were no noticeable defects or issues noted when activating the safety mechanism, and the samples worked as intended.The cause was not confirmed with received sample, and the division has been informed and will continue to monitor trends.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: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913572
• Report Number: 1417592-2026-51811
• Device Sequence Number: 5804198
• Product Code: FPA
• UDI-Device Identifier: 20193489010425
• UDI-Public: 20193489010425
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: DYNDTNBC23G7Z
• Device Lot Number: 240101
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2024
• 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: 07/26/2024
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (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