MAUDE Adverse Event Report: ICU MEDICAL, INC NON Y GRIPPER PLUS POWER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-3367-24
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device has not been returned to date.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 reportable information becomes available.
Event or Problem Description
It was reported that when the patient used it, the blood backflow could not be receded and the air receded.There was a patient involvement, but no harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: photos were provided for investigation.The photos show a gripper plus power sample and one label, the same reported in the complaint.It¿s not possible to identify the failure mode reported.The complaint was not confirmed.Root cause was not established.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc.Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint could not be confirmed and the root cause was unable to be determined.

• Brand Name: NON Y GRIPPER PLUS POWER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20032512
• Report Number: 3012307300-2024-07952
• Device Sequence Number: 17743623
• Product Code: FPA
• UDI-Device Identifier: 10610586033001
• UDI-Public: (01)10610586033001(17)280519(10)4396023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

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: Lay User/Patient
• Device Catalogue Number: 21-3367-24
• Device Lot Number: 4396023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 08/22/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/24/2024; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown