MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CATHETER, IV, SURESITE AUTO, 22G X 1

Catalog Number	DYNA22100Z
Medical Device Problem Codes	Activation Failure (3270); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "she withdrew the needle by pressing the button to retract the needle, but didn¿t notice that the button didn¿t work".
Additional Manufacturer Narrative
The customer reported that when the nurse stuck the patient and gained access, she withdrew the needle by pressing the button to retract the needle, but didn¿t notice that the button didn¿t work and in advertently stuck herself after sticking a patient; the area was "flushed/washed and bandage applied" and "labs obtained per protocol and no further symptoms or complications noted since." labs indicate a positive hep a for the nurse, and the patient lab results were still pending.Medline quality received 1 ea opened catheter, iv, suresite auto, 22g x 1.00 for evaluation; the needle on the sample received was already retracted so medline was unable to test the sample.With the sample received medline was unable to confirm the reported issue.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: DBD-CATHETER, IV, SURESITE AUTO, 22G X 1
• 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: 50882180
• Report Number: 1417592-2026-49656
• Device Sequence Number: 18589745
• Product Code: FOZ
• UDI-Device Identifier: 20193489140078
• UDI-Public: 20193489140078
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 09/23/2026

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: DYNA22100Z
• Device Lot Number: 27823020004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2023
• 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: 12/18/2023
• Initial Report FDA Received Date: 09/24/2026
• 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