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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
Model Number 598943P
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2021
Event Type  Malfunction  
Manufacturer Narrative

This is one of two reports submitted for the same event. Please reference mfr report #: 9616099-2021-04252. A total of 15 devices are being reported for the same lot number associated with this event/report. The devices are available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

As reported, twenty-eight (28) boxes of a. 098¿ 9f 55cm vista brite tip straight (str) guiding catheter had particulate matter of suspected cardboard fragments found inside its sterile pouch. There was no damage noted to the packaging of the device. The product was received and inspected by quality control at customer¿s on-site facility. The actual product was not damaged. This product was not used. It was taken out of its box and inspected. It was not involved in any procedure. The devices will be returned for evaluation.

 
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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 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key11304603
MDR Text Key234377946
Report Number9616099-2021-04253
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK925131
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number598943P
Device Catalogue Number598943P
Device LOT Number17852640
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/01/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/02/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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