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

Model Number 21-7105-24

Device Problems Volume Accuracy Problem (1675); Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported the disposable caused dosing issue or diversion issues with cadd pumps.The event affected patient care.

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: no lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.B3: date of event is unknown; d4: lot number, expiration date and are unknown;h4: device manufacture date is unknown.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17011141
• MDR Text Key: 316029647
• Report Number: 3012307300-2023-05754
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586022715
• UDI-Public: 10610586022715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7105-24
• Device Catalogue Number: 21-7105-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1