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

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Death (1802); No Code Available (3191)

Event Date 04/21/2020

Event Type  Death  

Event Description

Surgeon attempted to remove port-a-cath (implantable venous access system), but was unable to remove the entire catheter.Patient required second surgery where it was attempted to remove the remaining portion of the catheter.

• Brand Name: PORT-A-CATH
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10122785
• MDR Text Key: 194142918
• Report Number: 10122785
• Device Sequence Number: 1
• Product Code: LKG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 14600 DA