MAUDE Adverse Event Report: COSTA RICA PALINDROME HSI 19/36 KIT VT CE; DIALYSIS CATHETER

Model Number 8888145057C

Device Problem Cut In Material (2454)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dialysis catheter.The customer states that the patient came to the dialysis center with a tear/cut on venous extension of the catheter.The patient's bandage was bloody.The catheter was exchanged on (b)(6) 2014.The catheter was initially implanted (b)(6) 2014.Additional dialysis treatment was required.

Manufacturer Narrative

Submit date: 11/04/2014.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.The product sample consisted of one assembled 14.5 fr palindrome with slots, heparin coating and an anti-microbial sleeve catheter.After visual inspection, a cut was found on the venous catheters extension silicone tube, near the strain relief.During a functional test (underwater test), bubbles were detected coming out from the venous extension.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.Exercise caution when using sharp instruments near the catheter.The catheter tubing can tear when subjected to nicks, excessive force or rough edges.Inspect the catheter frequently for nicks, scrapes or cuts which could impair its performance.The device was in use for 6 months.The device was more likely damaged during use.The most probable root cause can be due to the device coming in contact with a sharp object.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 non-conforming product from leaving the manufacturing operations.A corrective action is not warranted at this time.As per procedure, manufacturing performs 100% leak testing 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.

• Brand Name: PALINDROME HSI 19/36 KIT VT CE
• 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: 4222821
• MDR Text Key: 17277487
• Report Number: 3009211636-2014-00141
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/24/2014

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: 8888145057C
• Device Catalogue Number: 8888145057C
• Device Lot Number: 304511X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 54 YR