MAUDE Adverse Event Report: COVIDIEN PALINDROME EMERALD 23/40 KIT; DIALYSIS CATHETER

Model Number 8888145044C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Dyspnea (1816)

Event Date 04/23/2014

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 reports that a diabetic patient.On (b)(6) 2014 had a palindrome h catheter 23/40 in inserted in the vena jugularis interna dex.Statlock is used.On (b)(6) 2014 the patient coughs as a result the catheter migrates exposing the cuff outside the exit site, in an arch between the exit site and the statlock, the catheter is removed.On (b)(6) 2014, a new palindrome h 28/45 catheter is placed in the vena jugularis interna sin.The catheter was always fixated with a statlock.Medical intervention required.No date or details on the intervention, 1.5 hours.

Manufacturer Narrative

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

Manufacturer Narrative

The manufacturing lot number associated with this complaint was not provided.Without the lot number, a device history record (dhr) review could not be performed.All dhrs are reviewed for accuracy prior to product release.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.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 nonconforming product from leaving the manufacturing operations.A corrective action is not warranted at this time.This information will be utilized for tracking and trending purposes to determine the need for corrective action.

• Brand Name: PALINDROME EMERALD 23/40 KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; 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: 4355217
• MDR Text Key: 5143289
• Report Number: 3009211636-2014-00204
• 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: 8888145044C
• Device Catalogue Number: 8888145044C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1