MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Model Number	8888572552
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports the tubing of the catheter continued to break apart when the physician went to use it.They had to replace the product.
Additional Manufacturer Narrative
An investigation of the reported condition was performed.A device history record (dhr) was reviewed and was confirmed that products were produced accomplishing quality requirements.Since the sample was not provided for evaluation the reported condition could not been confirmed and the pictures provided did not provide conclusive evidence of the reported condition.The root cause and corrective actions could not be identified.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, VENTRICULAR, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6965736
• Report Number: 1282497-2017-05411
• Device Sequence Number: 1324623
• Product Code: GBS
• UDI-Device Identifier: 30884521025466
• UDI-Public: 30884521025466
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 12/31/2021
• Device Model Number: 8888572552
• Device Catalogue Number: 8888572552
• Device Lot Number: 170200147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 01/17/2018
• Patient Sequence Number: 1