MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. GULT CADD MEDICATION CASSETTE 100ML; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7300-24

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

Hair detected in cadd cassette between inner bag and cassette.Fda safety report id# (b)(4).

• Brand Name: GULT CADD MEDICATION CASSETTE 100ML
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11982950
• MDR Text Key: 256038334
• Report Number: MW5101832
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7300-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1