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

Model Number	8888541028P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
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 use, they saw air bubbles in the arterial extension approximately half a centimeter after the bifurcate.Dialysis treatment was stopped, they stuck a plaster around the extension as an intervention and sent the patient to the doctor.The catheter was checked and after checking they decided to remove the catheter and inserted a new one.The catheter was not repaired, it was stated that there was no leak, tego was not utilized, there was no luer adapter issue and octenisept was the cleaning agent used.There was no reported patient injury.
Event or Problem Description
According to the reporter, during use, they saw air bubbles in the arterial extension approximately half a centimeter after the bifurcate.Dialysis treatment was stopped, they stuck a plaster around the extension as an intervention and sent the patient to the doctor.It was stated that flushing was done prior to treatment and they did not see anything and it was stated that the clamps are not moved to a new location after each treatment.The catheter was checked and after checking they decided to remove the catheter (catheter has been in place for 14 days) and inserted a new one.There was no other product being used with the device.The catheter was not repaired, it was stated that there was no leak, tego was not utilized, there was no luer adapter issue and octenisept was the cleaning agent used.There was blood loss of less than 1ml.There was no patient injury.
Additional Manufacturer Narrative
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the cannula was cut in two pieces.The red luer adapter, blue luer adapter, clamps and hub appeared intact.A functional evaluation found that the catheter was submerged into a water bath.The ends were clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the cut cannula may occur when mishandled during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 8640682
• Report Number: 3009211636-2019-00129
• Device Sequence Number: 11263901
• Product Code: MSD
• UDI-Device Identifier: 10884521158511
• UDI-Public: 10884521158511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2019

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 Expiration Date: 02/28/2022
• Device Model Number: 8888541028P
• Device Catalogue Number: 8888541028P
• Device Lot Number: 1812200184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 05/04/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1