MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE RESERVOIR, 100 ML

Device Problem Pressure Problem (3012)

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

Event Date 01/24/2016

Event Type  malfunction  

Event Description

Whtn the red cap was put on the extension (after removing the air from the cassette) the cap undid itself due to the high pressure in the cassette.No harm/injury noted to pt.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR, 100 ML
• Type of Device: CADD MEDICATION CASSETTE RESERVOIR, 100 ML
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 5403619
• MDR Text Key: 37353914
• Report Number: MW5059816
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/25/2016

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR