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

Model Number	8888145057C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/05/2019
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, during the flushing of the arterial lumen of the central venous catheter, the red ultem adaptor had broken off above the level of the clamp.A small piece of the catheter extension tubing was still attached to the adaptor.The line was clamped immediately and the end was attached.The line was then flushed and locked with heparin.The catheter extension has been repaired with the repair kit and the catheter is presently functioning well.The catheter had no previous repairs.There was no blood loss, blood transfusion, or patient injury.

• 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: 8439877
• Report Number: 3009211636-2019-00065
• Device Sequence Number: 13766462
• Product Code: MSD
• UDI-Device Identifier: 10884521083073
• UDI-Public: 10884521083073
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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 Model Number: 8888145057C
• Device Catalogue Number: 8888145057C
• Device Lot Number: Z4YH241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1