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

Catalog Number	21-4035-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text: d4 and g5 are unknown.No product information has been provided for these fields.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
A customer stated that there was an incident with device, which was not discovered prior to patient use and the event result in patient harm in extravasation of chemotherapy.Medical intervention was required where surgical removal and subcutaneous wash out.The outcome of the event is still ongoing.
Additional Manufacturer Narrative
Other, other text: h6.Evaluation codes: updated.Device evaluation: one sample was received in used condition.A visual inspection found no damage.During the functional testing, liquid flowed through the product without a problem.As an additional test the connection between the port and the catheter was verified.No discrepancies were found, the test successfully passed.The complaint was unable to be confirmed.A dhr review was completed and no non-conformances were found.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: DELTEC PORT-A-CATH PORTS
• Common Device Name: PORT, CATHETER, IMPLANTED, SUBCUTANEOUS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17704306
• Report Number: 3012307300-2023-08789
• Device Sequence Number: 6746115
• Product Code: LJT
• UDI-Device Identifier: 10610586023828
• UDI-Public: 10610586023828
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4035-24
• Device Lot Number: 4271437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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