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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7106-24
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2018
Event Type  malfunction  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information was received that the cadd extension set was leaking at the filter.Second one from the same batch.Patient wrapped the filtered section with a make-up pad and some tape to stop leak.No reported adverse effects.
 
Manufacturer Narrative
Device evaluation: one smiths medical cadd extension set was returned for analysis in an unused condition and with the original unopened packaging.The sample was visually inspected at a normal condition of illumination and no discrepancies were found.During analysis, leak test was performed using hydrostat vessel and no leaks were detected.Based on the evidence, the complaint was not confirmed, and no fault was found.
 
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Brand Name
CADD EXTENSION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8192514
MDR Text Key131309913
Report Number3012307300-2018-08898
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586023279
UDI-Public10610586023279
Combination Product (y/n)N
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/26/2023
Device Catalogue Number21-7106-24
Device Lot Number3611985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Date Manufacturer Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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