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

Model Number 21-7394-24

Device Problem Material Puncture/Hole (1504)

Patient Problem Fever (1858)

Event Date 05/14/2021

Event Type  Injury  

Event Description

Information was received indicating that while in use of a smiths medical cadd administration set, the nurse noticed that the tubing was pierced at the filter and the tubing was changed.It was also reported that the patient had a high fever the morning after and was prescribed an antibiotic treatment and blood culture was done.No further adverse effects were reported.

Manufacturer Narrative

Device evaluation: the device/sample was returned for investigation.A functional test was performed, and during the test, a leak was found.The reported failure was confirmed.The root cause of the reported failure could not be determined.There were no relevant findings detected in the dhr.

Event Description

Additional information was received indicating there was no clinical intervention required.Patient was prescribed an antibiotic treatment and blood culture done.

• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12057798
• MDR Text Key: 258050589
• Report Number: 3012307300-2021-06474
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 3988484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female