MAUDE Adverse Event Report: ICU MEDICAL, INC. NDL, GRIPPER MICRO, 22G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	3271
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: june 2025 is the reported month/year of the event, but the exact day was not provided.H3: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the needle is hard to remove when the safety function is activated, so customer used other products.The event occurred during patient use/administration at facility.There was no reported patient harm/adverse event.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn 3012307300-2025-10321-00 for details pertinent to this event.

• Brand Name: NDL, GRIPPER MICRO, 22G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22404180
• Report Number: 9617604-2025-00233
• Device Sequence Number: 8294332
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: (01)10610586029882(17)291211(10)6070870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: 3271
• Device Catalogue Number: 21-3271-24
• Device Lot Number: 6070870
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown