MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SFTY BLD COLL HLDR 21GX1.25"

Catalog Number	SBCH21G
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the rubber of the distal needle is not moving back into the correct place after the end user fills a vacutainer tube with blood.This is causing the needle to remain exposed and leak blood onto the next vacutainer that the end user is trying to fill.".
Additional Manufacturer Narrative
The customer reported receiving a medline blood collection set where the rubber piece would not return to its original position, and there was no reported death or serious injury associated with this event.A photograph was received; the photograph does not have a clear image of the rubber piece itself but it does show that there is blood leaking through while the vacutainer is connected to the blood collection set, and the manufacturer conducted first appearance testing and rubber cap rebound elasticity testing on retained samples.The retained samples were free of damage and defect, and after 5 punctures for each blood collection set the rubber cap was successfully rebound to its initial position; however, the cause was documented as "comp./part defective, broke" under supplier error.No trends were identified for the specified material number and its corresponding defect type, and there has been no change to the reportability decision associated with this complaint.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: SFTY BLD COLL HLDR 21GX1.25"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50842865
• Report Number: 1417592-2026-46629
• Device Sequence Number: 9957614
• Product Code: JKA
• UDI-Device Identifier: 10197344039708
• UDI-Public: 10197344039708
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200027
• 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): 09/21/2026

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: SBCH21G
• Device Lot Number: 241101
• 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: 12/10/2025
• Initial Report FDA Received Date: 09/21/2026
• 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