MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8811313015
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states that after installing the catheter is was found to be occluded.There was no patient adverse event.
Additional Manufacturer Narrative
Submit date: 2017-july-12 an investigation was performed.This complaint has not been confirmed.The actual sample involved in the reported incident was not returned for evaluation and no additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation or determine a root cause.A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure 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 dhrs are reviewed for accuracy prior to product release.If the sample is returned in the future, this complaint will be re-opened for further investigation.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.
Event or Problem Description
The customer states that after installing the catheter is was found to be occluded.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• MDR Report Key: 6666959
• Report Number: 3009211636-2017-05207
• Device Sequence Number: 16154752
• Product Code: FJS
• UDI-Device Identifier: 10884521004115
• UDI-Public: 10884521004115
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

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: 09/01/2021
• Device Model Number: 8811313015
• Device Catalogue Number: 8811313015
• Device Lot Number: 1627300081
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1