MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. NDL, GRIPPER PLUS, 22G; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2770-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the line had blockage.Saline did not seem to flow even after the clamp was released.There was no disinfection or sterilization, and no infectious disease occurred.This occurred before patient use during priming.There no patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn 3012307300-2025-05545 for details pertinent to this event.

• Brand Name: NDL, GRIPPER PLUS, 22G
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21638335
• Report Number: 9617604-2025-00193
• Device Sequence Number: 8536467
• Product Code: FPA
• UDI-Device Identifier: 10610586025631
• UDI-Public: (01)10610586025631(17)290818(10)6038029
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 21-2770-24
• Device Lot Number: 6038029
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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