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

Model Number	8888145017
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
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.In addition, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.The picture showed a catheter inside the patient with blood leaking from the venous extension.The instructions for use (ifu) state the customer must perform a visual inspection before using the device and that clamping the catheter repeatedly in the same spot could weaken the tubing.It also states to caution when using sharp instruments near the catheter because the catheter tubing can tear when subjected to excessive force or rough edges.The reported condition has been confirmed.Based on pictures provided by customer, it can be concluded that the most probable root cause can be considered as damaged during use caused by the use of strong cleaning agents, sharp objects, excessive force, or repeated clamping.No trends or triggers have been found.Therefore, no action is deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the middle of the extension tube was leaking.The catheter was replaced and there was no harm to the patient.

• 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: 7286389
• Report Number: 3009211636-2018-00053
• Device Sequence Number: 11091997
• Product Code: MSD
• UDI-Device Identifier: 10884521013193
• UDI-Public: 10884521013193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 07/08/2021
• Device Model Number: 8888145017
• Device Catalogue Number: 8888145017
• Device Lot Number: 1621800216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR