MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC DELTEC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-2767-24

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Patient Problem/Medical Problem (2688)

Event Date 09/04/2019

Event Type  Injury  

Event Description

It was reported that an epirubicin extravasasion was observed.The infusion was stopped as a result.A physician was informed of the incident.The physician subsequently explanted the existing porth-a-cath and replaced it with a new one.The explanted porth-a-cath was discarded by the facility.Following the incident, the patient experienced left subclavicular pain, eurytheme, and localized heat.No further adverse effects/patient complications were reported in relation to this event.

• Brand Name: DELTEC
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9135776
• MDR Text Key: 160611796
• Report Number: 3012307300-2019-05481
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025600
• UDI-Public: 10610586025600
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 21-2767-24
• Device Lot Number: 3829640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 62