MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; QUICK SWITCH VALVE,NON-STERILE

Catalog Number	ENFIT9000NS
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "port where needle is inserted is cracked, about a week ago.".
Additional Manufacturer Narrative
The customer reported that the port where the needle is inserted is cracked and that the item was inserted by physician.A physical sample was provided by the customer, and the sample was received in a very used condition with the medline logo on the knob very faded.Based on the sample provided, medline confirmed the reported issue that the male portion was broken off the entire piece.Cause could not be determined with the received sample, and the divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly 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: QUICK SWITCH VALVE,NON-STERILE
• 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: 50852426
• Report Number: 1417592-2026-47240
• Device Sequence Number: 9953875
• Product Code: PIF
• UDI-Device Identifier: 20193489012559
• UDI-Public: 20193489012559
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191759
• 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: ENFIT9000NS
• Device Lot Number: 89723010001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2023
• 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: 11/06/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown