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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PORTEX KITS; ANESTHESIA CONDUCTION KIT, PRODUCT CODE: CAZ
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PORTEX KITS; ANESTHESIA CONDUCTION KIT, PRODUCT CODE: CAZ Back to Search Results
Catalog Number NSE4200FC
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: returned device was received for evaluation.During the evaluation of the device after connecting the return device and our stock catheter, water was injected with a syringe, but no liquid leakage was seen from the flat filter and each connection part.The customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
Event Description
Information was received that a smiths medical pain management portex kit had leaked from the flat filter.No adverse patient effects were reported.
 
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Brand Name
SMITHS MEDICAL PORTEX KITS
Type of Device
ANESTHESIA CONDUCTION KIT, PRODUCT CODE: CAZ
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key10012634
MDR Text Key189439908
Report Number3012307300-2020-03353
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberNSE4200FC
Device Lot Number200124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2020
Date Manufacturer Received03/30/2020
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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