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

Model Number	8888160325
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 8/1/17.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 or Problem Description
The customer reports that the catheter slot cracked and leaked during ongoing therapy.
Additional Manufacturer Narrative
A devices history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this type of condition.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 product sample was received for analysis and investigation; it consisted in one unused uvc catheter, which came inside a pouch in a generic plastic bag.Visually the catheter did not show a defect.Under water testing was performed and there was no leak observed in the catheter.The sample evaluation revealed that the reported condition could not be confirmed.Based on this information the most probable cause was that the clinician confused blood residue with leaking.Blood residues could be caused by the treatment or other condition in the patient.With the available information this is the most possible root cause for this event.Additionally based on the event description, the condition was noticed during use, after priming the catheter.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time; therefore the most probable root cause can be considered as customer perception (blood residues were confused with leaking).There are no trends or triggers found for the reported condition, therefore, a corrective or preventive action is not deemed necessary at this time.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.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• MDR Report Key: 6757987
• Report Number: 3009211636-2017-05245
• Device Sequence Number: 11278738
• Product Code: FOS
• UDI-Device Identifier: 20884527005106
• UDI-Public: 20884527005106
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2016
• Device Model Number: 8888160325
• Device Catalogue Number: 8888160325
• Device Lot Number: 1506800117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 01/23/2018
• Patient Sequence Number: 1