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

Model Number	21-4083-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that after the patient was implanted in the infusion port, he found that the right breast and side of the chest were swollen with slight pain, and physical examination: the outer quadrant of the right breast and the tissue near the port seat of the side chest near the port of infusion were edematous, the skin was not red and swollen, and it was mildly tender.Contrast examination shows that there is a small amount of contrast agent in the catheter part, and after local treatment, local pain, swelling and other symptoms are relieved.Expert identification: 1 drug extravasation 2 catheter leakage.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: one (1) photo was attached to the complaint created.The photo was used to conduct the device analysis since the physical unit had not been received.The photo, an x-ray image, showed an implanted port-a-cath port and a catheter.In the image part of the catheter, a splat in the catheter was observed.Thus, the reported failure mode, leaking catheter, was confirmed from the photo provided.However, no product had been received to conduct a functional test.After reviewing the mitigations that were performed during the manufacturing process, and analyzing the photo provided, the root cause of the failure mode could not ne be determined.No corrective actions were required because the mitigations in place were revised and executed in accordance with procedure.This failure will continue to be monitored to determine if new actions need to be taken.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(6).

• Brand Name: DELTEC PORT-A-CATH II PORTS
• Common Device Name: PORT AND CATHETER, IMPLANTED,SUBCUTANEOUS,INTRAVAS
• 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; zhongshan city; minneapolis, MN 55442
• MDR Report Key: 15854472
• Report Number: 3012307300-2022-27454
• Device Sequence Number: 5076946
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 05/30/2023
• 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: Female