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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD CLEO SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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NULL CADD CLEO SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
It was reported that the patient said she did have issues with her site in december 2022.2nd issue, patient said the part that goes into your body for the infusion, a plastic piece fell off which has never happened to her before.No further information is available.No patient injury reported.
 
Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.No serial/lot number was provided; therefore, a device history record (dhr) review could not be conducted.
 
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Brand Name
CADD CLEO SUBCUTANEOUS INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key16304704
MDR Text Key308896051
Report Number3012307300-2023-00899
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2023
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
Date Manufacturer Received05/26/2023
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
Type of Device Usage Initial
Patient Sequence Number1
Patient Age45 YR
Patient SexFemale
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