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

Catalog Number 21-4035-24

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 08/15/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 322924374
• Report Number: 3012307300-2023-08789
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586023828
• UDI-Public: 10610586023828
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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