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

Model Number	21-4153-24
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a filtration problem occurred to a smiths medical deltec® port-a-cath® proport.It was decided to not use the port for chemotherapy administration and the port was then explanted.Upon explant of the port, it reported that the base of the reservoir had detached causing serum extravasation.The patient required surgical intervention and had a new port placed.No further adverse effects were reported.
Additional Manufacturer Narrative
Device evaluation: two (2) photos of a smiths medical deltec port-a-cath proport were received as well as one (1) smiths medical deltec port-a-cath proport returned for analysis in used condition inside a plastic bag.Visual inspection showed the insert was loose and could be removed from the housing, the septum was collocated in the right position but did not exceed the surface of the housing.Testing was conducted comparing three (3) ports that were pre-heated and then welded and three (3) ports that were not pre-heated and then welded.For each mode, one (1) each was pre-assembled with only hands and a leak test was performed.It was found that the sample that was not pre-heated failed.The investigation determined the most probable, but unconfirmed, sources of the reported issue to be deficiency of knowledge/process control on the ultrasonic machine and the operator did not detect that the port was not welded.Based on evidence and investigation, the complaint allegation was confirmed.Training was subsequently conducted to reinforce welding operation.

• Brand Name: DELTEC PORT-A-CATH PROPORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• MDR Report Key: 9810967
• Report Number: 3012307300-2020-01929
• Device Sequence Number: 3068659
• Product Code: LJT
• UDI-Device Identifier: 10610586012563
• UDI-Public: 10610586012563
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: No Information
• Device Expiration Date: 06/09/2024
• Device Model Number: 21-4153-24
• Device Catalogue Number: 21-4153-24
• Device Lot Number: 3829676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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