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

Model Number	8888413419
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, leakage was observed when the catheter was rinsed after placement.The catheter showed a vertical cut.No clinical consequences reported for the patient.
Additional Manufacturer Narrative
A device history 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.All dhr are reviewed for accuracy prior to product release.Sample consisted in one used catheter which came inside a generic plastic bag.Visual evaluation of the sample was performed; and it was observed that catheter has a vertical cut irregular.Magnified pictures were taken.The reported condition has been confirmed.Based on the sample evaluation revealed a cut that could to cause the leak reported by the customer.The catheter functioned as intended for an undetermined amount of time.Based on the available information there is enough information to discard manufacturing process.The most possible root because could be related to a customer misuse since the defect occurred after customer manipulation.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: PERITONEAL
• 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: 7286055
• Report Number: 3009211636-2018-00052
• Device Sequence Number: 13710169
• Product Code: FJS
• UDI-Device Identifier: 10884521004603
• UDI-Public: 10884521004603
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K862046
• 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): 04/24/2018

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: 05/10/2021
• Device Model Number: 8888413419
• Device Catalogue Number: 8888413419
• Device Lot Number: 1616000146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1