MAUDE Adverse Event Report: COVIDIEN PALINDROME RT 15FR 23CM KIT; DIALYSIS CATHETER

Model Number 8888541023

Device Problem Torn Material (3024)

Patient Problems Air Embolism (1697); Death (1802)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer reports the catheter tore apart at the y junction (bifurcate) during dialysis.The implantation date was (b)(6) 2014.As a result, there was an air embolism and the patient passed.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.The device was in use for approximately 5 months.The device was more likely damaged during use.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.Do not use sharp, jerking motions or undue force, this could tear the catheter.If the catheter offers resistance, do not pull further.This is considered an isolated incident and a corrective action is not applicable at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% visual assembly final inspection.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME RT 15FR 23CM KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4805335
• MDR Text Key: 5892109
• Report Number: 3009211636-2015-00250
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888541023
• Device Catalogue Number: 8888541023
• Device Lot Number: 319288X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death