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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 01/13/2021

Event Type  malfunction  

Event Description

Information was received indicating that a blind check was conducted on a cadd cassette reservoir and it was noticed that there was corrosion around the green tab on top of the cassette as well as inside of the hard plastic of the cassette.The day a patient's cassette was made, as the tech was going to gently tap the air bubbles out, there were droplets located on the inside of the hard outer plastic.The tech had to take all of the medication out and transfer it to a new cassette.There was no reported adverse event.

Manufacturer Narrative

Other, other text: h10: device evaluation: five smiths medical cadd cassette reservoir were returned for analysis in a used condition.Visual inspection was performed and indicated that the sample using did not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.That could cause the failure mode reported.During functional testing, samples units 1 and 2 pass the leak test; samples units 3, 4 and 5 were rejected by the leak test equipment.It is confirmed the failure mode reported.After leak testing was performed on the sample using a syringe in order to detect any leakage.The samples units present leaks in the join with the tube of the bag, therefore it is confirmed the failure mode reported.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.

• Brand Name: CADD CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11323856
• MDR Text Key: 231683602
• Report Number: 3012307300-2021-01226
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1