MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET WITH MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7052-24
Medical Device Problem Codes	Device Alarm System (1012); Failure to Deliver (2338); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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, the reported complaint could not be confirmed and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that there were creases in the tubing and the pump was alarming because no drug was getting from the cassette to the pump and through the line.The patient was delayed slightly in replacing their medication cassette as they had to waste a significant amount of cassettes and lines trying to find one that worked.The patient did not go without treatment for very long.No patient injury reported.

• Brand Name: CADD EXTENSION SET WITH MICROBORE TUBING
• Common Device Name: 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: 16673705
• Report Number: 3012307300-2023-03485
• Device Sequence Number: 20177824
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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
• Operator of Device: Health Professional
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown