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

Model Number 21-7394-24

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that at the end of therapy, it was not possible to flush the smiths medical cadd administration set.It was noted that there was only small volume of blincyto in the tubing.No adverse effects were reported.

Manufacturer Narrative

Other, other text: device evaluation- one used device was returned for evaluation.Examination showed no obvious defects.The device was given functional testing; this showed the tubing was partially occluded.It was determined the issue was likely caused by excess solvent being applied during manufacturing.The manufacturing facility reviewed the manufacturing process for this device type and reviewed the mitigations against this occlusion.This device type is 100% inspected visually and the device type is sampled for occlusion testing at regular intervals.The review determined the process (including mitigations) was being followed.

• 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: 11314601
• MDR Text Key: 231394731
• Report Number: 3012307300-2021-01164
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• 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: No Information
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 3984356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1