MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7059-24

Device Problems Inaccurate Delivery (2339); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: 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.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.If the device becomes available, smiths medical will re-open the complaint file and submit a supplemental mdr as necessary in accordance with 21 cfr 803.56.

Event Description

It was reported the disposable under infused.Device fell on the floor.No patient injury reported.No additional information available.

• Brand Name: CADD ADMINISTRATION SETS - NON FLOW STOP
• 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: 16790808
• MDR Text Key: 313774992
• Report Number: 3012307300-2023-04384
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020421
• UDI-Public: 10610586020421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2023

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: Health Professional
• Device Model Number: 21-7059-24
• Device Catalogue Number: 21-7059-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1