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

Catalog Number	21-4083-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was found to be broken, and the port end was removed by surgery.There was patient involvement, but no patient harm/adverse event reported.
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 reportable information becomes available.
Additional Manufacturer Narrative
H6.Codes: updated.No product was received for evaluation.Two photos were provided and used for analysis.One photo showed the lot number for the device and the second photo a port was observed where a catheter fragment can be observed under the port sleeve (section where catheter is connected to the port), sleeve appears to be locked since it is seated over the outlet tip tube.The complaint was confirmed.The root cause was unknown.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc.D9: date returned to mfg; 11/29/2024.Device evaluation: one device and two photos were received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Visual inspection was performed during analysis.The customer reported complaint was confirmed, and a break in the catheter was observed.The root cause was unable to be determined.

• Brand Name: DELTEC INTRAVASCULAR CATHETER
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20495145
• Report Number: 9617604-2024-00825
• Device Sequence Number: 17032708
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: (01)10610586023613(17)250406(10)3984419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• 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,Followup
• Report Date (Section B): 08/08/2025

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: Health Professional
• Device Expiration Date: 04/06/2025
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 3984419
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 03/28/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/05/2024; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• 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