MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC LUER GRIPPER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-3271-24
Medical Device Problem Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.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.
Event or Problem Description
It was reported that there was a possibility of root blockage as the remaining amount of chemical solution has not decreased.When it was disconnected from the connected disposable pca pump, it was confirmed that chemical solution was leaking from the pump route.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.He sample was prepared for use, and the needle was safely removed from the white cap.The infusion site was then flushed and no difficulties were observed.A free flow through the cannula was observed.The complaint of an occlusion cannot be confirmed nor replicated.The probable cause of the reported problem unknown.All functional test of the device passed.

• Brand Name: DELTEC LUER GRIPPER
• 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: 20471877
• Report Number: 9617604-2024-00806
• Device Sequence Number: 15354335
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: (01)10610586029882
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 21-3271-24
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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