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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 ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7394-24
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2024
Event Type  malfunction  
Event Description
It was reported the disposable wouldn't pass fluid through the line.All sets from this lot were affected.No adverse patient effects were reported by the customer.
 
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.
 
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Brand Name
CADD ADMINISTRATION SET
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 Key18995765
MDR Text Key339088157
Report Number9617604-2024-00266
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027536
UDI-Public10610586027536
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number21-7394-24
Device Lot Number4420462
Was Device Available for Evaluation? No
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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