MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXT SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 3856141

Device Problem Material Twisted/Bent (2981)

Patient Problems Diarrhea (1811); Pain (1994)

Event Date 12/01/2018

Event Type  Injury  

Event Description

Patient has diarrhea resolved with imodium and mild jaw pain.Patient also reports having problems with 2 extension sets.They kink up and block the medication.Reported to (b)(6) by patient/caregiver.Dose or amount: 39ng/kg/min, frequency: continuous, route: iv, dates of use: from (b)(6) 2019 to current, diagnosis or reason for use: pah.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8248578
• MDR Text Key: 133461583
• Report Number: MW5083096
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 3856141
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR