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

Model Number	8888541023
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample 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
According to the reporter, on (b)(6) 2017, when the gauze bandage was being removed, the device¿s plastic y-adapter loosened without force being applied.A new y-piece from another catheter was used in order to resolve the issue.There was no medical intervention required or harm to the patient.
Additional Manufacturer Narrative
Evaluation summary: 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 activities was acceptable.One catheter was received for analysis and investigation.Visual inspection showed the catheter was separated in two parts.The shaft assembly was not returned as part the sample.The snap connector showed damage.The device is assembled by the customer prior to use.As per the instructions for use (ifu), the customer must perform a visual inspection before using the device.The ifu provides guidance for the catheter¿s assembly.The ifu cautions to be sure the catheter end is advanced into the locking ring and seats fully against the hub making sure there is a tactile click and the connection is secure.Dimensional testing was done showing the product met specification requirements.Per the available information, a root cause could not be determined.Based on the available evidence the issue could not be related to the manufacturing process.As per procedure, manufacturing performs 100% visual assembly final inspections.This complaint will be used for track ing and trending purposes.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.

• 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: 7025217
• Report Number: 3009211636-2017-05346
• Device Sequence Number: 1275149
• Product Code: MSD
• UDI-Device Identifier: 10884521135482
• UDI-Public: 10884521135482
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2018

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: 05/31/2020
• Device Model Number: 8888541023
• Device Catalogue Number: 8888541023
• Device Lot Number: 1628800119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 01/02/2018; 01/02/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 01/19/2018; 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 74