MAUDE Adverse Event Report: COVIDIEN PALINDROME EMERALD 23/40KIT VT; DIALYSIS CATHETER

Model Number 8888145044

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that it was found that the adapter of the catheter had a slow leak during dialysis, and was unable to perform dialysis.The venous end has a crack.The physician replaced the adapter with another new one.There was no patient injury.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no non-conformances related to the reported issue for the involved lot.The sample was returned for investigation; it consisted of one catheter of the product mahurkar, 2 dilators (10 and 12), 1 guide wire and 1 needle introducer that came inside a generic plastic bag and did not present signs of use.It was observed that the blue adapter was not presented attached to the extension of the mahurkar catheter.This catheter was not related to this complaint since a palindrome catheter was reported.A blue adapter was returned detached from the extension; it presented signs of use (remains of blood).Visual inspection was performed and the blue adapter had a crack on the thread pitch area, the crack was at 270 degrees.Additionally, the adapter presented marks that could indicate the use of some instrument.The physician replaced the adapter with another new one and it could be determined that the blue adapter returned is related to the palindrome catheter reported by this complaint.The instructions for use (ifu) state that it is necessary to perform an inspection before using the device.Do not use the catheter if it is damaged or appears defective.Over tightening catheter connections can crack some adapters.Additionally, the adapter became damaged after being in use for an undetermined amount of time.The evidence provided is not enough to relate this event to the manufacturing operations.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and it functioned as intended for an undetermined amount of time; for this reason the adapter was more likely damaged during use and the most possible root cause can be considered over tightening the adapter.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 nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME EMERALD 23/40KIT VT
• 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: 5313209
• MDR Text Key: 34739791
• Report Number: 3009211636-2015-00517
• Device Sequence Number: 1
• Product Code: NYU
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

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: 8888145044
• Device Catalogue Number: 8888145044
• Device Lot Number: 307320X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1