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

Model Number 8888145045C

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

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 patient got the catheter implanted on (b)(6) 2014.The nurse discovered that the catheter was slipped out and cuff was visible outside of the skin.The catheter was removed.Medical intervention required.

Manufacturer Narrative

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

Manufacturer Narrative

The customer states that the catheter was implanted in the patient on (b)(6) 2014.Per the complaint notes, the incident date was (b)(6) 2014.The nurse discovered that the catheter had become loose and the cuff section of the catheter was now visible outside of the skin.The catheter was removed and medical intervention was required.No sample was returned for further evaluation.A device history record (dhr) review was performed for the lot number identified by the customer, 322716x.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: 4341415
• MDR Text Key: 5215285
• Report Number: 3009211636-2014-00203
• 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

• Date FDA Received: 12/18/2014
• 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: 322716X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer 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