MAUDE Adverse Event Report: SMITHS MEDICAL CADD 0.22 FILTER ADMIN SET

Catalog Number 21-73942

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2016

Event Type  Injury  

Event Description

Leak in administration set used to infuse intravenous cardiac inotrope therapy.Dates of use: (b)(6) 2016.Diagnosis or reason for use: cardiac myopathy requiring infusion of intravenous inotrope.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: CADD 0.22 FILTER ADMIN SET
• Type of Device: CADD 0.22 FILTER ADMIN SET
• Manufacturer (Section D): SMITHS MEDICAL; plymouth MN 55442
• MDR Report Key: 6185428
• MDR Text Key: 62858761
• Report Number: MW5066751
• Device Sequence Number: 1
• Product Code: FPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 21-73942
• Device Lot Number: 46X461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 112