MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. NDL, GRIPPER MICRO; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-3271-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated a chemical leak has occurred.The operator is requesting to investigate where and how it is leaking.The event occurred during use.There was no reported patient harm/adverse event.
Additional Manufacturer Narrative
D4: lot: unknown.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
G1 - mfg contact office city: corrected.D3 - postal code, h3, h6: updated.The suspect product was returned for evaluation.Visual inspection was performed and was found that there was a crack on the male luer portion of the set.Functional test was performed by attaching the suspect luer to syringe and injecting water into the port.A leak was observed.The allegation made by the complainant was confirmed.The probable root cause of the event was due to overtightening of syringe onto the luer port during use.

• Brand Name: NDL, GRIPPER MICRO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24937908
• Report Number: 3012307300-2026-03932
• Device Sequence Number: 20128742
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: (01)10610586029882
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 21-3271-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 07/02/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown