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

Model Number	21-4474-24
Medical Device Problem Codes	Partial Blockage (1065); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: recall z-0189-2020.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-11994
• Device Sequence Number: 19366935
• Product Code: LJT
• UDI-Device Identifier: 10610586039966
• UDI-Public: 10610586039966
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown