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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION GC 9F .098 STR 55CM CATHETER, PERCUTANEOUS

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CORDIS CORPORATION GC 9F .098 STR 55CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number 598943P
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2018
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17807995 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, a particulate was found in sterile pouch. A picture has been sent. The integrity of the sterile pouch was not compromised. The actual product was not damaged. There was no damage to the outer product box. The devices will be returned for analysis.
 
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Brand NameGC 9F .098 STR 55CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8174941
MDR Text Key131796489
Report Number9616099-2018-02593
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K925131
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number598943P
Device Lot Number17807995
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2018
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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