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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 EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7047-24
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Manufacturer Narrative
One sample was received for evaluation.Visual inspection found no damage or defects.Functional testing was unable to verify or duplicate the reported problem.No fault was found.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's tubing was completely severed from the connection port.No adverse patient effects were reported by the customer.
 
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Brand Name
CADD EXTENSION 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 Key19000359
MDR Text Key338932125
Report Number9617604-2024-00265
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586020315
UDI-Public10610586020315
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K942046
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 Number21-7047-24
Device Lot Number4396638
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2024
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2023
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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