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

Catalog Number	21-2766-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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 cannot inject the solution.There is a blockage.This occurred during priming in early (b)(6) 2025.
Additional Manufacturer Narrative
One used device was received for evaluation.Functional and visual tests were done, the reported issue was duplicated.A solvent membrane was observed in the inner diameter of the needle.The root cause of the issue was an errant solvent application error.A review of the device history record (dhr) indicated that all inspections were completed during manufacture, and no issues had been noted at that time.

• Brand Name: DELTEC GRIPPER PLUS 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23457083
• Report Number: 3012307300-2025-12011
• Device Sequence Number: 8916942
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: (01)10610586025594(11)300215
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 21-2766-24
• Device Lot Number: 6093229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown