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

Model Number	8888541019P
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the catheter's venous luer adapter was detached or disconnected from the feature manipulation engine(fme) generator.The patient lost 250ml of blood and 2 points of hemoglobin based on the blood numbering required by the physician.The patient was plugged again and finished the dialysis session.It was stated that when the catheter was used on fme generators, the luer lock could not be screwed completely and there was at least one turn of the screw missing which increases the disconnection risk.

• 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: 7621385
• Report Number: 3009211636-2018-00208
• Device Sequence Number: 11168743
• Product Code: MSD
• UDI-Device Identifier: 20884521158495
• UDI-Public: 20884521158495
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 8888541019P
• Device Catalogue Number: 8888541019P
• Device Lot Number: 1720700126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEATURE MANIPULATION ENGINE(FME) GENERATOR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention