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

Catalog Number	21-2947-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that nurse from the nasopharyngeal/chest tumor radiotherapy department was preparing to install an implantable intravenous drug delivery system for the patient.Upon pre-charging, she discovered a needle blockage, preventing the pre-filled fluid from passing through pipes, and she immediately discontinued it.There was unknown patient harm or adverse effects reported as a result of the event.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: DELTEC SPLIT-SEPTUM Y-SITE GRIPPER HUBER NEEDLE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21657913
• Report Number: 3012307300-2025-03125
• Device Sequence Number: 8271924
• Product Code: FPA
• UDI-Device Identifier: 10610586016776
• UDI-Public: (01)10610586016776(17)290521(10)6006089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K870866
• 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): 04/14/2025

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: 21-2947-24
• Device Lot Number: 6006089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/14/2025
• 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