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

Catalog Number	21-2961-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that there was an equipment malfunction encountered in the oncology day hospital (hdj) during a chemotherapy session.The nurse noticed a drop-by-drop leakage at the level of the gripper valve.Further on, it was noticed that the chemotherapy solution leaked onto the patient¿s clothing.The infusion was stopped and the patient¿s skin was decontaminated.At that time, no skin reaction has been observed.The patient was seen again, the next day for skin decontamination.There was patient involvement and no clinical consequences were reported.
Additional Manufacturer Narrative
Photos were received for evaluation for the complaint that a drop-by-drop leakage at the level of the gripper valve.The photos received the defect was not possible to confirm, samples and lot number was not received, therefore the corresponding test could not be possible to confirm, in case to receive the lot and the sample, the complaint will be re-open for perform the corresponding evaluation.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24303085
• Report Number: 3012307300-2026-01095
• Device Sequence Number: 5142310
• Product Code: FPA
• UDI-Device Identifier: 10610586027697
• UDI-Public: 10610586027697
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 21-2961-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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