MAUDE Adverse Event Report: ICU MEDICAL, INC. DELTEC; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4455-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during infusion of chemotherapy the patient felt pain.X-ray revealed a defect of the port a catheter device.During infusion of chemotherapy the patient felt pain.X-ray revealed a defect of the port a catheter.There was patient involvement, no serious injury.
Additional Manufacturer Narrative
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.Date returned to mfg: 26-feb-2025.H6.Investigation codes: updated.Investigation summary: received one (1) used list# unknown, port a cath.As received, the catheter was observed to be broken off from the rest of the catheter-port assembly.The port showed general wear and tear.The entirety of the catheter was not returned.The port and catheter assembly was researched to be item no.21-4455-24 from the lot number printed on the bottom of the port 4307487.The port-catheter assembly was primed using an icu provided needle and syringe as per ifu (instructions for use).No leaks were found on the port body and attached catheter.Scratches and markings were observed on the plastic body and septum, of unknown origin.The attached catheter was then removed, and the port connector was inspected.Minor scratches and markings were observed, of unknown origin.The other catheter segment returned was primed in the same manner as the port-catheter assembly, and no leaks were found.Without the return of the affected catheter segment, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Additional Manufacturer Narrative
H2) correction: d3 manufacturing establishment name updated.D4 lot number, catalog number, expiration date, and primary udi number corrected.H4 device manufactured date corrected.

• Brand Name: DELTEC
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; avenida calidad no.4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21399006
• Report Number: 3012307300-2025-01891
• Device Sequence Number: 8523514
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: (01)10610586032707(17)270626(10)4307487
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 4307487
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 04/11/2025; 04/09/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/02/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown