MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145044
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/01/2017
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, while undergoing dialysis, the device leaked due to a small hole where the catheter tube meets the bifurcate.The catheter was removed and replaced.There was no harm to the patient.
Additional Manufacturer Narrative
Evaluation summary: 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.The sample consisted of one catheter.The catheter came inside a plastic bag and it presented signs of use (blood residues).Functional testing was required (underwater test) for verify if the catheter present any leak.After this testing the catheter showed a leak below the hub.Visual inspection was performed and the catheter presents a small hole in the shaft where the leak occurred.Manufacturing performed 100% inspection for crack or leak which would identify this issue in the catheter.The reported condition has been confirmed.Based on the information, the device functioned as intended for an undetermined amount of time and this defect was not identified prior to use.It can be concluded that the product was manufactured according to specifications and functioned as intended, and a cause could not be related to manufacturing activities.The most probable root cause could be considered as customer misuse/perception (leak could be caused due to excessive force, sharp objects or due to an inappropriate use of cleaning agents.) 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: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7105156
• Report Number: 3009211636-2017-05390
• Device Sequence Number: 1461844
• Product Code: MSD
• UDI-Device Identifier: 20884521013244
• UDI-Public: 20884521013244
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: 03/08/2019
• Device Model Number: 8888145044
• Device Catalogue Number: 8888145044
• Device Lot Number: 1609800269
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR