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

Model Number	21-4083-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Swelling/ Edema (4577)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Serious injury.

• Brand Name: DELTEC PORT-A-CATH II PORTS
• Common Device Name: 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
• Report Number: 3012307300-2023-00983
• Device Sequence Number: 6201172
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown