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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Spontaneous call from (b)(6) an inpatient pharmacist at (b)(6) hospital requesting information on patient cadd extension tubing.All pertinent information regarding tubing was provided.Per inpatient pharmacist, patient is hospitalized due to motor vehicular accident and in need of urgent mri.No further information available or dates are known or were reported.All known information is contained on this form.Any additional information will be provided on a separate report.Reported to (b)(6) by health professional.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15209975
• MDR Text Key: 297780143
• Report Number: MW5111409
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: OPSUMIT 10MG, MFR: JNJ
• Patient Sex: Male