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 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

The product sample or additional supporting materials from the account was not available for this incident.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.There were no assembly or component issues identified.Without the physical product, a definitive root cause could not be identified.Post market vigilance will continue to monitor this condition for future potential action.Should new information become available, the file will be re-opened and the investigation will be amended as appropriate.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 connection of the arterial (red) connector and the extension tube.Then after a few weeks, while checking for permeability of the catheter, the venous (blue) had the same issue.It was stated that the connector was changed with the repair kit, distal connectors were changed and iv antibiotics was given as an intervention.It was stated that catheter was 1 year old.There was no reported patient injury.

Event Description

According to the reporter, during treatment, blood leak was noted coming from the connection of the arterial (red) connector and the extension tube.Then after a few weeks, while checking for permeability of the catheter, the venous (blue) had the same issue.It was stated that the connector was changed with the bard repair kit, distal connectors were changed and iv antibiotics was given as an intervention, chlorhexidine 2% alcohol 70 % was the cleaning agent used and tego adapter was the method used to tighten the adapters.It was stated that there was no significant blood loss due to the event.It was stated that catheter was 1 year old.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: 8293496
• MDR Text Key: 134717966
• Report Number: 3009211636-2019-00016
• 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: 03/15/2019

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: 02/21/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 91