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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 HIGH-VOLUME ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD HIGH-VOLUME ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7361-24
Device Problem Disconnection (1171)
Patient Problem Insufficient Information (4580)
Event Date 11/15/2023
Event Type  malfunction  
Event Description
It was reported that the device tubing became detached.It is unknown if there was patient involvement, no adverse patient effects were reported.
 
Manufacturer Narrative
H3: device not received by manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
 
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Brand Name
CADD HIGH-VOLUME 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 lane north
minneapolis, MN 55442
2247062300
MDR Report Key18521244
MDR Text Key332980205
Report Number9617604-2024-00052
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517191738
UDI-Public15019517191738
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/16/2024
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 Health Professional
Device Catalogue Number21-7361-24
Device Lot Number4415171
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/19/2023
Initial Date FDA Received01/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2023
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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