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

Model Number 8888145044P

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during treatment, blood leak was noted coming from the distal junction of the venous branch.It was stated that there was a break at this place.Treatment was not initiated as there was a risk of air entering the leak and pulmonary embolism.The venous branch was repaired with the repair kit and a dose of antibiotics was given as an intervention.There was no reported patient injury.

Event Description

According to the reporter, during treatment, blood leak was noted coming from the distal junction of the venous branch.It was stated that tego adapter was used to tighten the adapters and the cleaning agent used was chlorhexidine 2% alcohol 70 %.It was stated that there was a break at this place.Treatment was not initiated as there was a risk of air entering the leak and pulmonary embolism.The venous branch was repaired with the repair kit and a dose of antibiotics was given as an intervention.It was also stated that it was a luer adapter issue as the small leak came from under the white rubber part.There was no significant blood loss due to theleak.There was no reported patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8293613
• MDR Text Key: 134708764
• Report Number: 3009211636-2019-00018
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158092
• UDI-Public: 10884521158092
• Combination Product (y/n): N
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: 8888145044P
• Device Catalogue Number: 8888145044P
• Device Lot Number: 1628800104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1