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

Catalog Number	21-2770-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that there was a resistance when customer tried the test dose.It is unclear if it was inserted into the port.The event occurred during unknown time at facility.
Additional Manufacturer Narrative
H3: one opened and unused sample was received for evaluation.Visual inspection found no damage or anomalies.Functional testing was performed where the gripper needle was set to an approved icu syringe loaded with black dyed water, established flow with no resistance.Based on the analysis, the customer issue could not be confirmed.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; tijuana 22425
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22569187
• Report Number: 3012307300-2025-08789
• Device Sequence Number: 9247770
• Product Code: FPA
• UDI-Device Identifier: 10610586025631
• UDI-Public: (01)10610586025631(17)300310(10)6101743
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 21-2770-24
• Device Lot Number: 6101743
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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