MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC LUERACTIVE Y-SITE GRIPPER PLUS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2961-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the clamp was opened and the operator of the device tried to flow the chemical solution, the solution did not flow.There was no disinfection or sterilization, and no infectious disease occurred.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00150-00.The date of that submission was 20-feb-2025.B3.Date of event: month and year of event have been provided, but day is unknown.Investigation summary: received one (1) used.List #21-2961-24, ndl, gripper plus, 22g x.75" (19mm), needleless y-site.As received no damage or anomalies were observed.In attempts to replicate clinical use the female luer was accessed with a syringe with black dye provided by icu medical.It was observed that dye would not make it into the y-site.Upon further inspection errant solvent was observed at the tube y-site bond.The complaint of no flow can be confirmed.The probable cause is due to errant solvent application during manufacturing in tijuana.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: DELTEC LUERACTIVE Y-SITE GRIPPER PLUS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21890783
• Report Number: 3012307300-2025-04670
• Device Sequence Number: 17004753
• Product Code: FPA
• UDI-Device Identifier: 10610586025570
• UDI-Public: (01)10610586025570(17)290521(10)6006094
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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: 21-2961-24
• Device Lot Number: 6006094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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