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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UVC TRAY/5.0 FR PU CATHETER, UMBILICAL ARTERY

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COVIDIEN UVC TRAY/5.0 FR PU CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160432
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/23/2021
Event Type  Injury  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported a uvc fragment was incidentally identified in the nicu patient¿s aorta on imaging. The rn removed the catheter and noted it was not intact. The markings indicated there was 15cm missing. The uvc was inserted at another hospital. Additional information received stated, per staff interview, the standard process to remove a uvc is to clip the suture and then pull gently and slowly on the catheter for removal. The rn didn't notice anything unusual about removing the catheter following this process. The patient was transferred to an out of network facility and the retained arterial catheter was removed by the ir team. There were no identified complications caused by the retained arterial catheter.
 
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Brand NameUVC TRAY/5.0 FR PU
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20 calle #2 zona fra
alajuela
CS
Manufacturer (Section G)
COVIDIEN
edificio b20 calle #2 zona fra
alajuela
CS
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key12191994
MDR Text Key262412735
Report Number3009211636-2021-00759
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160432
Device Catalogue Number8888160432
Device Lot Number2102200111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/19/2021 Patient Sequence Number: 1
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