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

Catalog Number	21-2965-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).H3, h6: the device was not returned for analysis.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.The customer provided a video and photo of the product, and it be observed small drops going out of the y-site component.The investigation confirmed the customer reported leaking.Since the sample complaint was not returned for evaluation, the failure mode cannot be attributed to the manufacturing process.
Event or Problem Description
It was reported that the patient notified during shift handover that they had nutrition contents on their t-shirt.The gripper was observed to be in place, with no signs of extravasation.When checked, it was administered saline solution and leakage was noted at the proximal connection, with drops of fluid coming from it.Therefore, the total parenteral nutrition was suspended, the gripper was removed using the push-stop technique.The product had been used for 4 days.There was patient involvement, and there was no patient harm, and the consequence of the event was filtration.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; industrial internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22494109
• Report Number: 3012307300-2025-08251
• Device Sequence Number: 15481940
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: (01)10610586027734(17)300121(10)6078503
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 21-2965-24
• Device Lot Number: 6078503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PARENTERAL NUTRITION.; SALINE SOLUTION.
• Patient Age: 77 YR
• Patient Sex: Female