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

Catalog Number	21-3271-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that medical fluid leaked "from near the infusion site".The event occurred in late nov-2023.This occurred during patient use.No patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: month and year of event have been provided, day is unknown.E2 - incorrect due to system limitations.E2 - correct response: no, non-healthcare professional.H3 - other: device has not been returned to date.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: 1/8/2024, h3 and h6 - updated.Device investigation: one device was received for investigation.The complaint sample was visually inspected, at 12¿ to 16¿ under normal conditions.No damages or other defects were detected on the sample.During the functional test it was detected that the distilled water pass through the sample without difficulty.The reported complaint is not confirmed.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: DELTEC GRIPPER MICRO NEEDLESS 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: 18446985
• Report Number: 9617604-2024-00007
• Device Sequence Number: 15398851
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: (01)10610586029882(17)280718(10)4416256
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 21-3271-24
• Device Lot Number: 4416256
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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