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

Model Number 8888145044

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

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/30/2016.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 that blood was leaking from the connector of the catheter during dialysis treatment for the patient.There was a cleft (split) on the arterial side.The physician replaced it with a temporary catheter.There was no patient injury reported.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no nonconformance records related to the reported issue for the involved lot.No changes were identified that may impact the product or process related to reported condition during a period of six months prior to manufacturing date.Based on the reported information the complaint is related to a palindrome catheter, however a mahurkar catheter 11.5fr x 13.5cm was received with a marked guide wire, sealing cap, introducer needle, dilator 10fr, dilator 12fr and the original polybag of the product mahurkar with its respective label.These components did not present signs of use.The catheter was received without the blue adapter on the venous extension.A blue adapter was received detached from the extension.This adapter showed heavy signs of use.Visual inspection was performed and it was observed that blue adapter was cracked on the thread pitch area.Additionally, the adapter presents marks that indicate the use of an instrument.The arterial adapter and the extensions of the catheter received did not present any visible defects.Based on the complaint description that states that the physician used a temporary catheter to replace the defective adapter and the sample evaluation that revealed a catheter without signs of use and adapter with heavy signs of use, it could be concluded that the blue adapter received belongs to the palindrome catheter and the blue adapter of the mahurkar received was used use to replaced it.Manufacturing performed 100% inspection for cracked adapters per procedure and the incoming inspection was performed.The instructions for use (ifu) state that the customer has to perform an inspection before using the device.The reported condition has been confirmed.The evidence provided is not enough to relate this event to the manufacturing operations.Based on the available information, it can be concluded that the 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 as misuse.A health hazard evaluation (hhe) and corrective and preventative action (capa) will be addressing this failure mode.No further corrective or preventive actions are 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: matthew amaral ; 15 hampshire st; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5535883
• MDR Text Key: 41771399
• Report Number: 3009211636-2016-00140
• 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: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1