MAUDE Adverse Event Report: COSTA RICA PALINDROME 19/36 KIT W/ SLOT; DIALYSIS CATHETER

Model Number 8888145014

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with dialysis catheter.The customer stated that on (b)(6) 2014, catheter was inserted.On sept.23, the catheter tip was broken.The catheter was pulled and replaced with a new catheter the following day.The patient recovered withour further issues.

Manufacturer Narrative

Submit date: 11/25/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

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.There have been no changes related to the reported condition found within six months prior to the manufacturing date.The product sample consisted of one red adult adapter which was received within a generic plastic bag and presented signs of use since it was received separated from its extension.After visual inspection, a crack on the thread pitch area was identified.The instruction for use (ifu) states that it is necessary to perform an inspection before operating the device.Do not use the catheter if it is damaged or appears defective.Over tightening catheter connections can crack some adapters.The evidence provided is not enough to relate this event to the manufacturing operation.The device was returned within a generic plastic bag and presented signs of use which implies customer manipulation.Moreover, 100% of the devices are inspected for cracked adapters per procedure.Since the device was able to function as intended for approximately six months, the most probable root cause could be over tightening the adapter.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.

Manufacturer Narrative

The device history record was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.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.A corrective action is not warranted at this time.This information will be utilized for tracking and trending purposes to determine the need for corrective action.

• Brand Name: PALINDROME 19/36 KIT W/ SLOT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COSTA RICA; 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: 4276850
• MDR Text Key: 5033999
• Report Number: 3009211636-2014-00181
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 223641X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1