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

Device Problem Product Quality Problem (1506)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other text: b3 date of event unknown, d4: catalog number, lot number, expiration date and udi number is unknown, g5: 510k is unknown, no product information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the patient requested to send 2-3 extra tubing's with this order.Patient reported there was an issue with one of his previous tubing's and he had to replace it.Patient did not report any side effects.No missed dose or adverse event reported due to the issue with the tubing.Subcutaneous remunity self-fill patient.Defective product lot number and expiration date are unknown.No further details provided.Additional information received on (b)(6) 2023 via email date of event, lot number and item number unknown; patient details updated; outcome of event is resolved.

Manufacturer Narrative

Other, other text: no product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.

• Brand Name: CADD CLEO INFUSION 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: 17446779
• MDR Text Key: 320290925
• Report Number: 3012307300-2023-07755
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• 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
• Patient Sex: Male