MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. GRIPPER PORT-A-CATH NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2947-24
Medical Device Problem Code	Flushing Problem (1252)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient flushed the port in the catheterization clinic.When operating the saltwater exhaust, it was found that the exhaust could not be done.The needle was replaced with a new one, and no similar adverse events occurred, and there was no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: the device history record of reported lot number was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Complaint for the failure mode could not be confirmed by investigation as no samples nor pictures was provided by the customer.Without the return of the samples a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.

• Brand Name: GRIPPER PORT-A-CATH NEEDLES
• 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: 22002932
• Report Number: 3012307300-2025-05522
• Device Sequence Number: 20617020
• Product Code: FPA
• UDI-Device Identifier: 10610586016776
• UDI-Public: (01)10610586016776(17)290625(10)6023331
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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: Other
• Device Catalogue Number: 21-2947-24
• Device Lot Number: 6023331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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