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

Model Number 21-4155-24

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Infiltration into Tissue (1931)

Event Type  Injury  

Event Description

Information was received that upon administration of chemotherapy through a smiths medical deltec implantable port, filtration and extravasation occurred.A peripheral route was installed as a result to administer pending chemotherapy treatment.

• Brand Name: SMITHS MEDICAL DELTEC IMPLANTABLE PORTS
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 9740028
• MDR Text Key: 180791371
• Report Number: 3012307300-2020-01538
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586012594
• UDI-Public: 10610586012594
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K994216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability