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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEONATAL UMBILICAL VESSEL CATHETER

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COVIDIEN UNKNOWN NEONATAL UMBILICAL VESSEL CATHETER Back to Search Results
Model Number UNKNOWN NEONATE
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 03/18/2016. An investigation is currently underway. Upon completion, the results will be forwarded. Several attempts to gather information from the customer were made. To date, no response has been received. If additional pertinent information becomes available, the report will be updated.
 
Event Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc). The customer reports that the tip of an umbilical catheter broke off inside of a (b)(6) baby. It was unknown what the results of the cath lab were. There was no injury reported. The product was administered sometime in 2005, no other information was given.
 
Manufacturer Narrative
A lot number was not provided, therefore, it is not possible to perform a device history record (dhr) review. All dhr¿s are reviewed for accuracy prior to product release. Because the sample was not returned, there is not enough evidence to determine what could cause this event. Because the sample was not returned, there is not enough evidence to determine what could have caused this event. The following possible causes for the failure may be attributed to: operator error, instructions for use (ifu)¿s not followed: connections, infused substances, inspection not performed adequately, material composition. However, without the sample it is not possible to determine a specific root cause for this issue. Should the sample be returned in the future, this complaint will be re-opened for further investigation. In-process controls such as personnel training, incoming quality acceptance testing for raw material, 100 in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations. As per product specification, manufacturing performs 100% pressure testing during production, which would identify this issue in the catheter assembly. This complaint will be used for tracking and trending purposes.
 
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Brand NameUNKNOWN NEONATAL
Type of DeviceUMBILICAL VESSEL CATHETER
Manufacturer (Section D)
COVIDIEN
covidien manufacturing solutions sa
edificio 820 calle #2 zona france coyol
alajuela
CS
Manufacturer (Section G)
COVIDIEN
covidien manufacturing solulfons sa
edificio 820 calle #2 zona franca coyol
alajuela 20101
CS 20101
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key5510849
MDR Text Key40948563
Report Number3009211636-2016-00126
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN NEONATE
Device Catalogue NumberUNKNOWN NEO
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 Received05/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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