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

Model Number 8888145014

Device Problem Material Separation (1562)

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

Event Date 08/16/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer states that cuff separated from the catheter.The catheter was pulled and replaced with a new one.

Manufacturer Narrative

Submit date: 11/11/2014.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 were no non-conformances related to the reported issue.The product sample was returned within a generic plastic bag and it presented signs of use.It consisted of a 14.5 fr tal palindrome with slots catheter, 19 cm implant length and 36 cm overall length.Visual inspection was performed and it was observed that the cuff was not present on the catheter tubing.There is some glue noted on the tubing.As per the instructions for use (ifu), it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.To remove the catheter, free the cuff from the tissue and pull the catheter gently and smoothly.Do not use sharp, jerking motions or undue force.This could tear the catheter.The product sample was returned to the manufacturing site for review, it shows the cuff was present on the catheter when it was used by the customer.With the available information, the probable root cause was more likely caused due to use of sharp objects.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 leak inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% visual inspection at the final stage of production, which would identify this issue in the catheter assembly.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: 4242481
• MDR Text Key: 15327022
• Report Number: 3009211636-2014-00152
• 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: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• 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: 113223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• 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