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

Model Number 8888145044C

Device Problems Loose or Intermittent Connection (1371); Insufficient Flow or Under Infusion (2182)

Patient Problem No Information (3190)

Event Date 03/06/2014

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.On (b)(6) 2014 the patient coughs and low flow occurs.It was found that the cuff is 2cm exposed outside the exit site.Sutures were not removed but loosened during coughing.The catheter is removed and a new catheter placed on a later date.Medical intervention was required but there no date or details available on the intervention, procedure duration was 1.5 hours.

Manufacturer Narrative

(b)(4).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.This information will be utilized for tracking and trending purposes to determine the need for corrective action.A corrective action is not warranted at this time.

• 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 hamphire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4359391
• MDR Text Key: 15320218
• Report Number: 3009211636-2014-00205
• Device Sequence Number: 1
• Product Code: NYU
• 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: 05/08/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2015
• 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