MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. DELTEC PROPORT PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	21-4155-24
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that one month following implant of a smiths medical deltec® proport port, it was found in poor condition.The patient went to the operating room to verify port function under x-ray.Chemotherapy was discontinued and the port was explanted.No further adverse effects were reported.
Additional Manufacturer Narrative
Evaluation results: one deltec proport port was returned for investigation.The sample was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.The plastic port assemblies were found to be loose.This product problem was attributed to a manufacturing defect.

• Brand Name: DELTEC PROPORT PORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9618351
• Report Number: 3012307300-2020-00611
• Device Sequence Number: 16824798
• Product Code: LJT
• UDI-Device Identifier: 10610586012594
• UDI-Public: 10610586012594
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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 Expiration Date: 10/16/2023
• Device Model Number: 21-4155-24
• Device Catalogue Number: 21-4155-24
• Device Lot Number: 3717706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/11/2020
• 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 Age: 76 YR
• Patient Weight: 61