MAUDE Adverse Event Report: COSTA RICA KIT 11.5FX19.5 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8813793013

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/10/2014

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 the dressing was applied to the patient.An hour after, blood stains were noticed on the dressing of the catheter.During removal, the catheter was bleeding.The catheter tube was actually cut at the level of the swan neck.Another device was used to complete the procedure successfully.There were no consequences for the patient.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The customer states that a dressing was applied to the patient.An hour after, blood stains were noticed on the dressing of the catheter.During removal the catheter was bleeding.The catheter tube was actually cut at the level of the swan neck.Another device was used to complete the procedure successfully.There were no consequences for the patient.It was reported that the customer discarded the catheter, so the sample was not returned and could not be further evaluated.Sample and lot number information was not provided, 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: KIT 11.5FX19.5 CE MAHURKAR
• 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: 4223357
• MDR Text Key: 5060826
• Report Number: 3009211636-2014-00142
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/31/2014

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: 8813793013
• Device Catalogue Number: 8813793013
• 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: 11/04/2014
• 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