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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMALLBORE 6 INCH EXT VLV, 7 DAY INTRAVASCULAR ADMINISTRATION SET

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SMALLBORE 6 INCH EXT VLV, 7 DAY INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 20039E7D
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: (b)(6). Initial reporter zip: (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported smallbore 6 inch ext vlv, 7 day had flow issues and was clogged/blocked/occluded. The following information was provided by the initial reporter: "unable to prime the tube with saline despite max pressure exerted. ".
 
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Brand NameSMALLBORE 6 INCH EXT VLV, 7 DAY
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12464760
MDR Text Key271306611
Report Number9616066-2021-52019
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number20039E7D
Device Lot Number21025043
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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