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

Model Number	21-4155-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Extravasation (1842); Infiltration into Tissue (1931)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One video was returned for analysis.From review of the video, it was observed that the plastic port assembly was loose.Relevant documents and manufacturing process were reviewed and deemed adequate.The ultrasonic weld operation, visual inspection process, set-up of ultrasonic welder, and training records were reviewed; no discrepancies were found.Based on the evidence, the complaint was confirmed.The root cause was found to be from manufacturing as the lack of knowledge of the operation of the welding machine and lack of process controls in the ultrasonic machine.
Event or Problem Description
Information was received indicating that a patient receiving chemotherapy through a smiths medical deltec® proport ports implantable access system was noted to have infiltration and leakage into their tissue.Subsequently, the port was explanted and discarded with no further adverse effects.

• Brand Name: DELTEC PROPORT PORTS IMPLANTABLE ACCESS SYSTEMS
• 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: 9730095
• Report Number: 3012307300-2020-01365
• Device Sequence Number: 19368016
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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: 12/05/2023
• Device Model Number: 21-4155-24
• Device Catalogue Number: 21-4155-24
• Device Lot Number: 3736572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/19/2020
• 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