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

Model Number 21-7052-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems Diarrhea (1811); Headache (1880)

Event Type  malfunction  

Event Description

Information was received indicating that the cadd extension set leaked from the purple patient end.It was reported that the patient went without medications for several hours due to the malfunction.The patient felt unwell.Then had to endure side effects of sudden start of medication when reconnected (headache, flushing, diarrhea) which lasted in one of the cases for a couple of days.It was a significant contributor to patient anxiety.To continue therapy, the patient reattached and remade her medication as needed and symptoms resolved.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; glossop road; minneapolis, MN 55442
• MDR Report Key: 11408763
• MDR Text Key: 234613312
• Report Number: 3012307300-2021-01735
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7052-24
• Device Lot Number: 4025966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1