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

Model Number 21710624

Device Problem Obstruction of Flow (2423)

Patient Problem Inflammation (1932)

Event Type  Injury  

Event Description

Spontaneous.Inbound call from patient.Patient has no issues with current iv line.She said they just changed it in the hospital, she was discharged from hospital on (b)(6) 2022 (admitted date and length of stay was not provided).She said she was in the hospital for a blockage in her iv line, it was inflamed, but she said it was not infected.She said her iv line was in for a year and became blocked so they had to place a new iv line.She was given iv antibiotics in the hospital to prevent urinary tract infection.She doesn't remember the name of the antibiotic, but she is no longer taking them post discharge.She said her new iv line is fine/no issues.She stated md is aware of the hospitalization.No further information provided product lot number and expiration date were systematically retrieved from the dispensing system.Reported to cvs/caremark by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16043374
• MDR Text Key: 306207459
• Report Number: MW5113971
• 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: 11/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 21710624
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Patient Sequence Number: 1
• Treatment: PUMP; VELETRI
• Patient Outcome(s): Hospitalization
• Patient Sex: Female