MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH II PORTS; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASC

Model Number 21-4083-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems Extravasation (1842); Pain (1994); Swelling/ Edema (4577)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported the patient has a history of infusion port drug importation, swelling and pain in the right breast and side chest after infusion in the hospital, accompanied by slight pain; at physical examination, edema in the outer quadrant of the right breast and side chest and adnexal tissue of the port of infusion port, no redness and swelling of the skin, mild tenderness; contrast examination to see a small amount of contrast agent around the port seat; after local treatment, local pain, swelling and other symptoms are relieved, expert identification: 1 drug extravasation 2 infusion port seat leakage.

Manufacturer Narrative

Device evaluation was completed.The product has been discarded by the hospital.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

Manufacturer Narrative

Serious injury.

• Brand Name: DELTEC PORT-A-CATH II PORTS
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASC
• 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; no. 1 tianhe road; minneapolis, MN 55442
• MDR Report Key: 16315257
• MDR Text Key: 309022099
• Report Number: 3012307300-2023-00983
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-4083-24
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 4222399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention