MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. GRIPPER PORT-A-CATH NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2947-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a nurse was preparing to perform maintenance on a patient's infusion port.While priming, she suddenly stopped using it after discovering that it was clogged.She then replaced it with a new implantable intravenous drug delivery system.No similar adverse events were observed, and no harm was caused to the patient.There was patient involvement, but no harm was reported.
Additional Manufacturer Narrative
The device history record of reported lot number 6099785 was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the complaint will be reopened for further investigation.

• Brand Name: GRIPPER PORT-A-CATH NEEDLES
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23529635
• Report Number: 3012307300-2025-12366
• Device Sequence Number: 9083895
• Product Code: FPA
• UDI-Device Identifier: 10610586016776
• UDI-Public: (01)10610586016776(17)300304(10)6099785
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K870866
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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 Catalogue Number: 21-2947-24
• Device Lot Number: 6099785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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