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

Model Number 8888145044

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/30/2016 an investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer reports it was found there was a leak with the connector of the catheter during dialysis treatment for the patient.There was a cleft (split) on the venous side.The physician replaced it with a new catheter.There was no patient injury reported.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The sample consisted of a mahurkar catheter 11.5fr x 13.5cm that is different than the product reported.The red adapter showed signs of use.Visual inspection was performed and it was observed that red adapter was detached from the extension and the extension was broken.A crack was found on the arterial adapter on the thread pitch area.The adapter presents marks that indicate the use of some instrument.Manufacturing performed 100% inspection for cracked adapters per procedure and the incoming inspection was performed.The instructions for use (ifu) state that the customer should perform an inspection before using the device.Additionally, the adapter became damaged after being in use for an undetermined amount of time.The reported condition has been confirmed.The evidence provided is not enough to relate this event to the manufacturing operations.The most possible root cause can be considered as misuse; the instructions for use were not followed causing adapter over tightening.No complaint triggers or trends were identified.This event will be addressed through a corrective and preventative action (capa) and health hazard evaluation (hhe), no additional actions were required.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 manuf. solutions sa; edificio 820 calle#2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5536252
• MDR Text Key: 41766555
• Report Number: 3009211636-2016-00142
• 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: 03/16/2016

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: 03/16/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1