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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

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COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 03/23/2017. An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states there is a pin point hole on the catheter that caused leaking of droplets of blood while the infant is being held by his mother. Minor loss of blood as a result. The catheter was removed from the infant.
 
Manufacturer Narrative
Submit date: 03/30/2017. Additional information regarding the product issue was received from the customer. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The cord and skin were cleaned with betadine and alcohol per protocol. The agents are allowed to dry for optimal antimicrobial effect. The customer did not hear that the insertion was difficult. There was no difficulty securing the product. It is loop sutured to the umbilical jelly, then secured to the skin with tegaderm atop extra thin duoderm. The catheter was inserted in the umbilical vein for continuous use on (b)(6) 2017 and removed (b)(6) 2017. Either 3 ml or 10 ml 0. 9% nacl syringes were likely used to flush the line. Nothing is used to clean the device. It is inserted under sterile procedure. It is not cleaned after insertion. The device was replaced with a peripheral iv. The patient is progressing. Discharged to hospital closer to home.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6430125
MDR Text Key70749591
Report Number3009211636-2017-05047
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot NumberUNKNOWN
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 Received02/22/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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