• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN PALINDROME EMERALD 23/40 KIT; DIALYSIS CATHETER Back to Search Results
Model Number 8888145044C
Device Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 01/07/2016
Event Type  malfunction  
Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer of the palindrome h 23 cm on (b)(6) 2016 without complications.The catheter was sutured.Before connecting to dialysis on this day, the nurse discovered a leakage, and discovered a hole on one of the silicone extenders situated midway on the extension line.The patient had to go through a change of the catheter with no other complications.
 
Manufacturer Narrative
The device history record (dhr) was reviewed and no deviations related to this condition were found.There are no non conformance reports (ncr)¿s related to the reported issue and lot.The product sample was returned for investigation; it consisted of one part of the extension tube with a length of 3 cm approximately.A visual inspection was performed and no imperfections were found on the tubing.Functional testing was conducted and the product extension did not present any imperfections.Based on the complaint description the condition was not identified prior the insertion and the device functioned as intended for the first hours.Additionally, manufacturing performs a 100% visual inspection on catheter extensions and a 100% high pressure (leak) test.The product specification was reviewed in order to identify the possible root causes for the leaking.The most probable root cause could occur during use caused due to the use of sharp objects, repeated clamping or other similar damage as described in the instructions for use.Should the sample be returned in the future, this complaint will be re-opened for further investigation.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.Manufacturing performs a 100% leak test and a 100% visual inspection during production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 20101
CS   20101
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key5357173
MDR Text Key35971223
Report Number3009211636-2016-00031
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/07/2016
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 Number8888145044C
Device Catalogue Number8888145044C
Device Lot Number322716X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/07/2016
Initial Date FDA Received01/11/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/28/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age76 YR
-
-