MAUDE Adverse Event Report: COSTA RICA PALINDROME EMERALD 28/45 KIT; DIALYSIS CATHETER

Model Number 8888145045C

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 07/24/2014

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 states that on (b)(6) 2014, the patient stretched her arms above her head during the dialysis treatment.She was sitting in the dialysis chair and she felt that something slipped out.The clinicians discovered by examination that the cuff was visible 4 cm outside the skin.The catheter was placed on (b)(6) 2014.The catheter was pulled and replaced on (b)(6) 2014.The patient was hospitalized due to complicated internal and external bleeding around the site.Requiring pain relief.No information provided about prescribed medication or infection.

Manufacturer Narrative

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

Manufacturer Narrative

Submit date: 01/20/2015 the customer states that on (b)(6) 2014 during dialysis treatment the patient stretched her arms above her head.The patient was sitting in the dialysis chair and upon stretching immediately felt that the catheter had moved.The clinicians discovered that the cuff section of the catheter was now visible by approximately 4 cm outside of the skin.The catheter had originally been placed on (b)(6) 2014; it had been noted that the catheter had been working well during dialysis.On (b)(6) 2014, the catheter was pulled and replaced.The patient was hospitalized due to complicated internal and external bleeding around the site of the catheter.The patient required pain relief; no additional information was provided about any prescribed medication or infection.The lot number information was not provided, so a device history record (dhr) review could not be performed.The complaint was investigated, but since no sample was returned to covidien the defect could not be confirmed and the probable root cause cannot be determined.Complaint trending information is being reviewed on a monthly basis by covidien and if a trend is observed, actions are taken as necessary.It should 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 information will be utilized for tracking and trending purposes to determine the need for corrective action.

• Brand Name: PALINDROME EMERALD 28/45 KIT
• 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; edificio 820 calle #2; zona franca coyol; alajuela ; CS
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 4341365
• MDR Text Key: 5198513
• Report Number: 3009211636-2014-00202
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 11/20/2014

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: 8888145045C
• Device Catalogue Number: 8888145045C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2015
• 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