MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8811313015
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 dhr are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of this photo was performed.In the image it was appreciated that one person clinician has a pd catheter in the hands.In these picture showed a kinked in the shaft of the catheter near the cuff.In addition the device showed signs of use.The reported condition has been confirmed with the photo provided by the customer.Based on the available information, it can be concluded that product was manufactured according to specifications and it functioned as intended for the reported amount of time.It can be concluded that the catheter was more likely damaged during use.The most probable root cause can be considered as misuse.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process cont rols 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
According to the reporter, the catheter shaft was kinking and rolling.There was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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 dhr are reviewed for accuracy prior to product release.One photo was provided by the customer.Visual evaluation of this photo was performed.In the image, it was appreciated that one person clinician has a pd catheter in the hands.This picture showed a kinked in the shaft of the catheter near the cuff.Visual inspection of the sample revealed the same condition of the photo a kink near the cuff; besides, the catheter present signs of use which indicates that it was manipulated.The reported condition has been confirmed.The evidence provided is not enough to relate this event to the manufacturing operations.Based on the available information, it can be concluded that product was manufactured according to specifications and it functioned as intended for the reported amount of time; it can be concluded that the catheter was more likely damaged during use.The most probable root cause can be considered as misuse.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls 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, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7270192
• Report Number: 3009211636-2018-00044
• Device Sequence Number: 1343234
• Product Code: FJS
• UDI-Device Identifier: 10884521004115
• UDI-Public: 10884521004115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2018

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: 02/28/2018
• Device Model Number: 8811313015
• Device Catalogue Number: 8811313015
• Device Lot Number: 1305000037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 02/21/2018; 02/21/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 03/09/2018; 03/15/2018; 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1