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

Model Number 8888145039P

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

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 dialysis, when the arterial lumen locking solution was aspirated, blood leak was noted around the luer lock of the catheter's extension.It was also stated that the treatment was delayed until the luer (arterial) was repaired with a repair kit.The treatment occurred 3 hours after the usual schedule time.Alcoholic chlorhexidine was used as cleaning agent in the device.Tego was utilized and a crack was observed in the luer adapter.The insertion site was treated prior to product placement and there was no patient symptoms or complication associated with this event.There was a blood loss of approximately 2 milliliters and there was no medical intervention done to the patient.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: only the red adapter was received.The red luer adapter appeared intact with no signs of cracks.The extension tube was cut very close to the adapter.Microscopic evaluation: the adapter was visualized via microscopic evaluation and it was confirmed that no cracks were present.Functional testing: functional testing would normally include leak testing however the tube was cut too close to the adapter precluding this type of testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9717830
• MDR Text Key: 193394897
• Report Number: 3009211636-2020-00049
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158023
• UDI-Public: 10884521158023
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: 8888145039P
• Device Catalogue Number: 8888145039P
• Device Lot Number: 1833800160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 60