MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC STANDARD PAC LL IMPLANTABLE PORT KIT; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4452-24
Medical Device Problem Codes	Break (1069); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that during surgery that the port chamber was defective and could not be used.The valve protruding from the port chamber was loose.The incident occurred intraoperatively during the port insertion procedure.There was no patient involvement, no patient injury was reported.
Additional Manufacturer Narrative
One used unit was received for evaluation.Eight customer images were also provided showing the sample and the product box information.As received, the septum chamber in the port was observed to be loose and the catheter port connection moves around and not in a fixed position.Functional testing was performed and no leakage or anomalies were noted.However, it is understandable that a clinician may be concerned about any unexpected play in the product during use.The complaint of a loose component can be confirmed.However, the condition was not found to affect the function of the device and meets all current design requirements.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: DELTEC STANDARD PAC LL IMPLANTABLE PORT KIT
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, 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: 24344348
• Report Number: 3012307300-2026-01268
• Device Sequence Number: 10041465
• Product Code: LJT
• UDI-Device Identifier: 10610586032677
• UDI-Public: (01)10610586032677(17)250909(10)6140284
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K07265
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: Lay User/Patient
• Device Catalogue Number: 21-4452-24
• Device Lot Number: 6140284
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown