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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEO MEDICAL INC. 4FR V-CATH PICC SELDINGER
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NEO MEDICAL INC. 4FR V-CATH PICC SELDINGER Back to Search Results
Model Number 4029-1660
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2014
Event Type  malfunction  
Event Description
Leaked by clamp on lumen.
 
Manufacturer Narrative
This report c-2014-00010-rma#(b)(4) was assessed to be an mdr based on our mdr reporting criteria.Additional info will be submitted once the product has been returned for evaluation and a completed complaint.Investigation analysis (b)(4) has been completed.Included in this report filing is: medwatch 3500a report#: 300720796-2014-00003 and disclaimer.
 
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Brand Name
4FR V-CATH PICC SELDINGER
Type of Device
4FR V-CATH
Manufacturer (Section D)
NEO MEDICAL INC.
sparks NV
Manufacturer Contact
1375 greg st ste 108
sparks, NV 89431
7752842834
MDR Report Key4392402
MDR Text Key5432402
Report Number3007207906-2014-00003
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2016
Device Model Number4029-1660
Device Catalogue Number4029-1660
Device Lot Number1056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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