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

Model Number 8888145043P

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the catheter fell out.It was stated that the tissue attenuation into the cuff seemed to be delayed or absent.The catheter was secured with sutures for an extended period of time but in this situation, it was stated that the cuff was clearly exposed.The catheter was inserted and was removed.There was no patient injury.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7582840
• MDR Text Key: 110578160
• Report Number: 3009211636-2018-00174
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158078
• UDI-Public: 10884521158078
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2018
• Device Model Number: 8888145043P
• Device Catalogue Number: 8888145043P
• Device Lot Number: 1508600095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2018
• Date Device Manufactured: 04/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1