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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE CATHETER, UMBILICAL ARTERY

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COVIDIEN MFG SOLUTIONS S.A. ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  malfunction  
Manufacturer Narrative
Product id: (b)(4), lot no: 1616000159. An investigation of the reported condition was performed. A device history review revealed no discrepancies that may have contributed to a complaint of this issue mode. All quality assurance testing performed during manufacturing was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements. In addition, all dhr are reviewed for accuracy prior to product release. The sample consisted in 1 used uvc catheter. The sample came inside a generic plastic bag. During visual inspection, the catheter revealed that the sample was manipulated. Magnified picture was taken and irregular cut below the strain relief was observed. The product sample was returned to the manufacturing site for review. Based on the available information, it can be concluded that product was manufactured according to specifications; therefore the most probable root cause can be considered as unintentional misuse; this product was most likely damaged during use caused due to inappropriate manipulation by the user. No complaint triggers or trends were identified. No harm was reported, and therefore no corrective or preventive actions are required. It must be noted that 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. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Submit date: 04/25/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
 
Event Description
The customer reports the catheter is leaking at the hub where the catheter connects to the plastic piece.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6519126
MDR Text Key247570865
Report Number3009211636-2017-05094
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2021
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1616000159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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