MAUDE Adverse Event Report: ST PAUL CLEO SUBQ DISPOSABLES; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Separation Problem (4043); Difficult or Delayed Separation (4044)

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

Event Type  malfunction  

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.No lot number provided for dhr.

Event Description

It was reported that "the cleo tubing sometimes comes off from the pump while in use and she feels that it pulls the subcutaneous site too hard when changing tubing." field nurse informed to contact patient for alternatives.Patient does not have information about the tubing that she was referring to: did the reported product fault occur while in use with a patient? no.No missed doses reported; "did the product issue cause or contribute to patient or clinical injury? no.No adverse event reported: is the actual device is available to be returned for investigation? no: is the infusion life-sustaining? yes; what is the outcome of the event? resolved? ongoing.Reported to (b)(6) by pt/caregiver.

• Brand Name: CLEO SUBQ DISPOSABLES
• 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: 14111430
• MDR Text Key: 289261996
• Report Number: 3012307300-2022-06372
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 06/01/2022
• 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: Female