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

Model Number 8888145045C

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

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 catheter became dislodged during dialysis treatment and fell out.The insertion date was (b)(6) 2014.Dislodgement date (b)(6) 2014.No patient injury.The sample was not retained.

Manufacturer Narrative

Submit date: 09/09/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The product sample was not returned and no photos were received.The manufacturing lot number associated with this complaint was 362321.This defect has not been confirmed.The product sample was not returned to the manufacturing site for review.With the available information, the most probable root cause could be attributed to the employed insertion/placement method which affected the catheter's adherence.However without the sample, this cannot be confirmed.No additional actions are required.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.Per procedure, manufacturing performs 100% visual and dimensional inspection, in order to avoid a cuff issue in the catheter.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME EMERALD 28/45 KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN MANUFACTURING COSTA RICA; alajuela 00002 0101; CS 000020101
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; alajuela 2010 1; CS 20101
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 4157131
• MDR Text Key: 17573885
• Report Number: 3009211636-2014-00073
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• 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?: Yes
• Date Manufacturer Received: 10/09/2014
• 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