MAUDE Adverse Event Report: COVIDIEN PALINDROME 23/40 KIT W/ SLOT; DIALYSIS CATHETER

Model Number 8888145015

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

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 stated that when conducting the dialysis, the catheter joint was oozing and it failed to conduct dialysis.The service was less than three months.The problem was found post-procedure.The patient was involved with no injury.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There were no non-conformances related to the reported issue for the involved lot.The product involved is 8888145015, palindrome 23/40 kit w/ slot, lot# 302429x.The sample return consisted of one incomplete mahurkar dual lumen straight shaft catheter kit w/straight extensions, 13.5 fr x 16 cm.The sample received was different than the product reported.Inside the kit included a 10 fr dilator, a 14 fr dilator, a marked guide wire, j-straight, an introducer needle, guide wire and an assembled catheter.Visual inspection was performed and it was observed that the sample received did not present signs of use.The customer later reported that the returned adapter is from the reported palindrome catheter, not the returned mahurkar.The blue adapter was detached, cut from the extension tubing and it was not present in the kit.The red adapter was reviewed in order to confirm the reported condition; however the adapter did not present any issues.Although the reported condition was not confirmed through the sample evaluation this investigation will be focused on evaluating the cause of the possible failure mode for the luer adapter-leaking.The involved finished good lot and raw material lots were reviewed and the catheter assemblies do not reveal any deviation of the current procedure that might have contributed to the reported condition.There were no non-conformances opened for all the assembly levels, raw materials and incoming components.There has been no process changes that may impact the product/process related to the reported condition.The instructions for use (ifu) states 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.Based on the sample received, the reported condition was not confirmed.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.It can be concluded that the adapter was more likely damaged during use.Moreover, 100% devices are inspected for cracked adapters per procedure.Based on the available information, the most probable root cause is over tightening of the adapter.This failure is being addressed through a corrective and preventive action (capa).No additional actions are required 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 nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME 23/40 KIT W/ SLOT
• 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: 4785534
• MDR Text Key: 5798327
• Report Number: 3009211636-2015-00243
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 302429X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1