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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD CLEO; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD CLEO; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7221-24
Device Problem Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 01/31/2024
Event Type  malfunction  
Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
 
Event Description
It was reported the disposable exhibited a "luer lock connector fault".Unknown if there was an adverse patient harm/adverse event.Four disposables were affected.
 
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Brand Name
CADD CLEO
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
ave calidad no. 4, parque
tijuana
MX 
Manufacturer Contact
reed covert
6000 nathan ln n
minneapolis, MN 55442
2247062300
MDR Report Key18869352
MDR Text Key337689596
Report Number9617604-2024-00217
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30610586028407
UDI-Public30610586028407
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/08/2024
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 Lay User/Patient
Device Catalogue Number21-7221-24
Device Lot Number4308588
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2024
Initial Date FDA Received03/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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