MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888541023P

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states there is air passage on the arterial branch.

Manufacturer Narrative

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 MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer (Section G): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6424343
• MDR Text Key: 70561774
• Report Number: 3009211636-2017-05041
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/28/2017

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 Model Number: 8888541023P
• Device Catalogue Number: 8888541023P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: 02/28/2017
• Supplement Dates FDA Received: 10/02/2017
• 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