MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC LUERACTIVE Y-SITE GRIPPER PLUS W/ NEEDLELESS Y-SITE; 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	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that fluid leaked from the base of the needleless connector site during use.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D5.Other operator of device: operator of device is unknown.E1.Initial reporter phone#: unknown.No information has been provided to date.H3.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
Device evaluation: one sample was returned in used condition without original packaging.A visual inspection found that the sample was returned manipulated and without the needle cover.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 did not pass through the sample.The failure mode was not confirmed, according with the result of the functional test the sample was occluded.No non-conformances were found during the dhr review.

• Brand Name: DELTEC LUERACTIVE Y-SITE GRIPPER PLUS W/ NEEDLELESS Y-SITE
• 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: 18832526
• Report Number: 9617604-2024-00199
• Device Sequence Number: 7438918
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: (01)10610586027734(17)281203(10)4442223
• 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): 08/23/2024

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: Other
• Device Catalogue Number: 21-2965-24
• Device Lot Number: 4442223
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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