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

Model Number	8888145039P
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
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 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.
Additional 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
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9717830
• Report Number: 3009211636-2020-00049
• Device Sequence Number: 14053730
• Product Code: MSD
• UDI-Device Identifier: 10884521158023
• UDI-Public: 10884521158023
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 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
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 60