MAUDE Adverse Event Report: ST PAUL DELTEC TITANIUM PORT-A-CATH; IMPLANTABLE PORT

Model Number 21-4474-24

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: recall z-0189-2020.

Event Description

It was reported that upon opening it was noticed that the tip of the catheter is closed on the port side.No injury or patient involvement.

Manufacturer Narrative

The complainant returned unit was visually inspected under normal conditions of illumination according to the procedure visual inspection.One (1) tip of the catheter was found squashed; failure mode reported was confirmed.No other analysis was required.The most probable root cause for the occurrence was that the catheter was trapped in the seal of the kit, and it was not detected.The root cause was traced to shipping damage/manufacturing.For corrective action, manufacturing personnel were notified by the area supervisor as awareness of the failure mode reported by the customer.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC TITANIUM PORT-A-CATH
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14704385
• MDR Text Key: 295891058
• Report Number: 3012307300-2022-11994
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586039966
• UDI-Public: 10610586039966
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

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
• Device Operator: Health Professional
• Device Model Number: 21-4474-24
• Device Catalogue Number: 21-4474-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1