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

Model Number 8888145045C

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 07/25/2014

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 on (b)(6) 2014 after the dialysis treatment was completed, the nurse discovered that the catheter was slipped out and cuff was visible outside of the skin.The catheter was implanted on (b)(6) 2014.The catheter was pulled an replaced with a new one (b)(6) 2014.The patient was hospitalized.No information provided related to additional treatment.

Manufacturer Narrative

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

Manufacturer Narrative

The customer states that on (b)(6) 2014 after the dialysis treatment was completed, the nurse discovered that the catheter the cuff section of the catheter was now visible outside of the skin.The catheter had originally been implanted on (b)(6) 2014.On (b)(6) 2014, the catheter was removed and replaced with a new catheter.The patient was hospitalized; and no information was provided related to any required treatment.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 dhr review indicated that there was no quality issues associated with the reported defect mode.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: 4337362
• MDR Text Key: 18629236
• Report Number: 3009211636-2014-00199
• 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: 12/17/2014
• 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
• Patient Outcome(s): Other