MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Event Description

Information was received indicating that when filling the smiths medical cadd cassette reservoir, the bag has been breaking in the cassette, leaking the medication.It was reported that a syringe attached at the end was used to add drug and it started to leak out of the cassette.No patient consequences were reported.No adverse effects were reported.

Manufacturer Narrative

Other, other text: device evaluation: one smiths medical cadd medication cassette was returned for analysis in used condition without its original packaging.Visual inspection showed no discrepancies.Functional testing involved leak testing using a syringe.The device leaked on the joint of the tube with the bag.One possible, but unconfirmed, problem source was listed as a faulty bag sealer.Based on evidence and investigation, the complaint allegation was confirmed.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11094963
• MDR Text Key: 224310128
• Report Number: 3012307300-2020-12852
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 3962247
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1