• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported the line separated from the hub where they merge on the catheter.The line had been put in the same calendar day but split away leaking fluids and meds onto the baby.This baby was born shortly before the line placement the line was in less than 24 hours.No air was noticed on the patient side and no obvious harm to baby girl.
 
Manufacturer Narrative
Submitted 12/11/2018 an investigation was performed for the reported customer complaint: the customer reported the line separated from the hub where they merge on the catheter.The line had been put in the same calendar day but split away leaking fluids and meds onto the baby.This baby was born shortly before the line placement the line was in less than 24 hours.No air was noticed on the patient side and no obvious harm to baby girl.A review of the device history record (dhr) for lot no: 1801000071 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARGYLE
Type of Device
CATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7611322
MDR Text Key111435548
Report Number3009211636-2018-00204
Device Sequence Number1
Product Code FOS
UDI-Device Identifier20884527005113
UDI-Public20884527005113
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/12/2022
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1801000071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/04/2018
Initial Date FDA Received06/18/2018
Supplement Dates Manufacturer Received06/04/2018
Supplement Dates FDA Received12/11/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-