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

Model Number	8811313015
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer states during use they noticed the catheter was leaking and upon further examination found a crack of the catheter about one inch from the exit site.There was no harm to the patient.
Additional Manufacturer Narrative
Evaluation summary: a device history record (dhr) review was performed and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.One used sample was received for analysis and investigation.The sample showed signs of use.Under water testing was performed and a leak was observed on the catheter.Magnified pictures were taken, and showed that the sample has a cut.The reported condition has been confirmed.Based on the available information there is enough information to discard the manufacturing process.The most possible root cause could be related to customer use.No trends or triggers have been found.A corrective and preventive action (capa) is not 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: 6875215
• Report Number: 3009211636-2017-05299
• Device Sequence Number: 1444189
• Product Code: FJS
• UDI-Device Identifier: 10884521004115
• UDI-Public: 10884521004115
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 11/19/2020
• Device Model Number: 8811313015
• Device Catalogue Number: 8811313015
• Device Lot Number: 1535300098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR