MAUDE Adverse Event Report: ICU MEDICAL, INC. DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-3467-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device exhibited a leakage from the seal area.There was no patient involvement, no injury was reported.
Additional Manufacturer Narrative
One used unit was received for evaluation.A video was also provided showing leakage at the y-site outlet tube, and a picture was provided showing the packaging labeling.As received no damage or anomalies were observed on the product.Functional testing was performed, and leakage was confirmed between the y-site outgoing tube bond.Further inspection of the bond showed spotty solvent coverage.The reported issue was confirmed.The probable cause is due to insufficient solvent coverage application during assembly in tijuana.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• 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: 23694571
• Report Number: 3012307300-2025-13060
• Device Sequence Number: 16046107
• Product Code: FPA
• UDI-Device Identifier: 10610586033063
• UDI-Public: (01)10610586033063(17)300422(10)6093285
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072657
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 21-3467-24
• Device Catalogue Number: 21-3467-24
• Device Lot Number: 6093285
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown