MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX13.5 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8813817009

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/16/2016.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 the technician has seen an air bubble while performing dialysis and suspected that there is crack in the ultem adapter, but did not specify whether it is the venous line adapter or arterial line adapter.The dialysis was stopped and a fresh catheter was inserted.The complaint catheter was inserted on (b)(6) 2016.

Manufacturer Narrative

Submit date: 09/30/2016 the product involved in this complaint and the lot number is 8813817009/ kit 11.5fx13.5 ce mahurkar, lot number 1521700117.The device history record (dhr) was reviewed and no deviations related to this reported condition were found.There are not ncrs related to the reported issue for the involved lot.Quality inspections of final visual and physical evaluations results indicated that the product met specification requirements.The product sample was received for analysis and investigation.The catheter came inside a generic plastic bag and presented signs of use.A visual inspection of the sample revealed that the blue and red adapters present a crack on the thread pitch area.In the cavity 2 and 8 at 90 and 270 degrees from the injection point respectively.Additionally, the adapters present marks that could indicate the use of some instrument.Based on sample provided and event description, the adapter was cracked after being in use for a period of time without problems.Based on the adapter¿s conditions there is evidence of excessive force or the use of an inappropriate instrument to manipulate the adapters.Manufacturing performed a 100% visual inspection and 100% pressure test that would identify any cracked or leak in the catheter; therefore this potential cause could not be confirmed.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; therefore it can be concluded that the adapter was more likely damaged during use.The most probable root cause can be considered as unintentional misuse.As per the instructions for use adapter over tightening can cause a crack in the palindrome catheter.This issue is being addressed by a formal corrective and preventative action.No additional 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: KIT 11.5FX13.5 CE MAHURKAR
• 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 20101 ; CS 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5658060
• MDR Text Key: 45922167
• Report Number: 3009211636-2016-00219
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

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: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1521700117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR