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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF JR 4 100CM FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION CATH F5 INF JR 4 100CM FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 534521T
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2018
Event Type  Malfunction  
Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available. A review of the manufacturing documentation associated with lot 17771425 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, 5f jr4 infinity catheter did not connect well with a 3-way non-cordis connector extension line. There was no reported patient injury. Afterwards, a 6f jr4 infinity catheter was used and it worked fine. When the sales rep went to pick up the product, the connector was tested with other devices and it operated well.

 
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Brand NameCATH F5 INF JR 4 100CM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key7906623
MDR Text Key121726348
Report Number9616099-2018-02410
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK970854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 05/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2021
Device Catalogue Number534521T
Device LOT Number17771425
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/11/2018
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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