MAUDE Adverse Event Report: COVIDIEN PALINDROME RT 15FR 55CM KIT; DIALYSIS CATHETER

Model Number 8888541055

Device Problem Air Leak (1008)

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

Event Date 04/28/2016

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) 2016 that a customer had an issue with a dialysis catheter.The customer reports that there was an air intake issue at the level of the arterial connection of the dialysis catheter.The catheter was applied on (b)(6) 2015 on the right femoral.The surgery time was extended.The branches of the catheter had to be changed.

Manufacturer Narrative

Submit date: 07/21/2016.The actual sample involved in the reported incident was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation.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 dhr are reviewed for accuracy prior to product release.If the sample is returned in the future, this complaint will be re-opened for further investigation.The available information was analyzed and it did not allow confirming a root cause for the event, however, the possible root causes for the failure could be: incoming inspection not performed, in-process inspection not performed, defective material, malfunction, misuse, or over torque.No trends or triggers have been found, therefore, a corrective or preventive action (capa) is not deemed necessary 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 performed in the plant are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

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.No changes were identified that may impact the product/process related to reported condition during a period of six months prior to manufacturing date.Quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.The product sample was received for analysis and investigation; it consisted in a section of a palindrome rt catheter.Initially the sample was returned and was decontaminated prior to returning the product to the plant.According to the original condition of the sample received, the catheter presented signs of use (blood residues).The sample was received at the plant and according to visual inspection the arterial adapter has a crack on the thread pitch area, in the cavity 4 at 270 degrees from the injection point, additionally the adapter presents marks that could indicate the use of some instrument.The blue adapter did not present any problem.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 functioned as intended for a period of 4 months approximately; therefore this potential cause could not be discarded.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 the report amount of time.The adapter was more likely damaged during use.The most probable root cause was adapter over tightening.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 RT 15FR 55CM KIT
• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5688539
• MDR Text Key: 46208650
• Report Number: 3009211636-2016-00238
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888541055
• Device Catalogue Number: 8888541055
• Device Lot Number: 329735X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1