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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 8888160556
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
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 reports upon insertion of a 5 fr dual lumen uvc when physician aspirated for blood return from the vessel, it was noted that there were air bubbles coming into the syringe. Upon closer inspection of the line, there was found to be a small crack in the hub of the uvc catheter where the line connects to the microclave (of the primary, clear lumen) which is causing air to enter into the syringe with aspiration. The uvc line had to be removed from the vessel and a new double lumen uvc had to be placed with more difficulty than the initial attempt.
 
Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer reports upon insertion of a 5 fr dual lumen uvc when physician aspirated for blood return from the vessel, it was noted that there were air bubbles coming into the syringe. Upon closer inspection of the line, there was found to be a small crack in the hub of the uvc catheter where the line connects to the microclave (of the primary, clear lumen) which is causing air to enter into the syringe with aspiration. The uvc line had to be removed from the vessel and a new double lumen uvc had to be placed with more difficulty than the initial attempt. ¿ a review of the device history record (dhr) for lot no. 1624400139 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. Manufacturing also performs 100% leak testing for this device, which would identify this issue in the catheter assembly process. Analysis concluded there were no assembly component related issues. One (1) argyle polyurethane umbilical vessel catheter was received for evaluation. The visual inspection of the returned product noted no abnormalities. Functional testing was performed by submerging the catheter into a water bath. The end was clamped and a syringe was used to inject air to observe leakage. No air bubbles were present. Both extensions were tested with acceptable results. The investigation was unable to determine a root cause or establish a relationship between the device and the reported incident. No enhancements or improvements were generated for the reported condition. The reported customer complaint is not confirmed. A root cause could not be determined. This complaint will be utilized for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameARGYLE
Type of DeviceCATHETER, 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 Key7611638
MDR Text Key111440489
Report Number3009211636-2018-00205
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2021
Device Model Number8888160556
Device Catalogue Number8888160556
Device Lot Number1624400139
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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