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

Catalog Number	21-2965-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the huber needle was unable to be primed by flushing with saline before accessing the patient.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
Date of event: month and year of event have been provided, but day is unknown.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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
D9.Date returned to mfg: 31-may-2024.Investigation summary: one (1) sample was returned under part number 21-2965-24, l/n: 4420104 for evaluation without its original packaging, inside a plastic bag in decontaminated condition.The complaint sample was visually inspected, at 12¿ to 16¿ under normal conditions of illumination.No damage or other defects was detected on the sample.The sample was evaluated by introducing distilled water with a syringe to verify that the liquid flowed correctly.During the functional test it was detected that the distilled water passed through the sample without difficulty, no occlusion was detected in the sample.The failure mode ¿a0350 - occluded/blockage¿ reported in the complaint was not confirmed.No root could be determined because the complaint was not confirmed.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 LUER ACTIVE Y-SITE GRIPPER PLUS 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19302327
• Report Number: 9617604-2024-00425
• Device Sequence Number: 15174284
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: (01)10610586027734(17)280809(10)4420104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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: 4420104
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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