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

Catalog Number	21-2767-24
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no product returned for device analysis; a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that when the nurse went to remove the gripper, the needle did not make the usual click, and the safety needle was found detached from the system, causing her to prick herself.When removing the needle, it whipped out sideways, pricking the nurse and also tearing the skin of the child carrying the reservoir.The status of the product at the event was after connecting to the patient, while take out the needle to finish the treatment.There was no patient involvement or adverse event reported but was a delay in critical therapy.
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The device was visually inspected and there was no damages.A functional test was performed and the reported issue was not confirmed.The cause of the reported issue was unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23476182
• Report Number: 3012307300-2025-12131
• Device Sequence Number: 10228652
• Product Code: FPA
• UDI-Device Identifier: 10610586025600
• UDI-Public: (01)10610586025600(17)300710(10)6133330
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 01/05/2026

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: 21-2767-24
• Device Lot Number: 6133330
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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