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 Consequences Or Impact To Patient (2199)

Event Date 10/25/2014

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.After 8 months, the catheter fell out of the patient's body.The product was tested prior to use.The catheter was replaced with a new one.No report of infection.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Product sample was not returned for evaluation, but a photo was provided by the customer.The image shows the catheter tubing with its cuff missing.The remaining glue and some cuff felt can be seen on the catheter.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.Do not use a sharp, jerking motion or undue force; this may tear the catheter.It is important to free the cuff and surfaces from the tissue prior to removal.The photo given by the customer provides evidence to confirm the issue.The image sample shows evidence of cuff adherence as it presents felt filaments and glue residue in a very observable level.The event description stated that the catheter was tested prior to use and additionally functioned as intended for eight (8) months, therefore it can be concluded that the device was more likely damaged during use.The product sample was not returned to the manufacturing site for review.With the available information, the most probable root cause would be due to excessive force or a jerking motion.However without further information, this cannot be confirmed.The device history record (dhr) review was performed.The dhr review indicated that there were no quality issues associated with this reported condition.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.As per procedure, manufacturing performs 100% visual and dimensional inspection and 100% assembly final inspection respectively, which would identify cuff defects in the catheter assembly.This complaint will be used for tracking and trending purposes.

• 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: 4221154
• MDR Text Key: 4970890
• Report Number: 3009211636-2014-00140
• 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
• Report Date: 10/25/2014

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: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 212420X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 11/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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